EU-GMP and PIC/S GMP are two terms that frequently appear together when pharmaceutical companies build new facilities, upgrade their quality systems, or prepare for GMP inspections. Because the technical content of the two systems is highly aligned, many people assume that PIC/S GMP is a “lower-level” version of EU-GMP, or that EU-GMP represents a higher certification level than PIC/S GMP. This interpretation does not accurately reflect the nature of the two systems.

The most important difference is not whether one system requires cleaner rooms, more HEPA filters, or stricter microbiological control. EU-GMP operates within the pharmaceutical legal and regulatory framework of the European Union, while PIC/S — the Pharmaceutical Inspection Co-operation Scheme — is a co-operative arrangement between regulatory authorities aimed at harmonising GMP standards and inspection practices across countries and jurisdictions.

PIC/S officially states that the PIC/S GMP Guide is maintained in harmony with the EU GMP Guide. The two guides have developed in parallel for decades and are described by PIC/S as being “practically identical” in most areas. PIC/S also uses the expression “equivalent but not identical” to describe their relationship.

Therefore, the most useful question for a pharmaceutical manufacturer is not simply, “Which standard is higher, EU-GMP or PIC/S GMP?” A more accurate question is: Where will the product be manufactured, which regulatory authority will inspect the site, which market will the product enter, and what level of pharmaceutical quality system is required to meet those expectations?

What are EU-GMP and PIC/S GMP?

GMP stands for Good Manufacturing Practice. In the pharmaceutical industry, GMP is a system of principles designed to ensure that medicinal products are consistently manufactured and controlled according to quality standards appropriate for their intended use. GMP is not limited to facilities or production equipment. It covers personnel, materials, equipment, documentation, testing, deviation management, qualification, validation, and the entire pharmaceutical quality system.

EU-GMP generally refers to the Good Manufacturing Practice principles and guidelines applied within the pharmaceutical regulatory system of the European Union. One of the central references is EudraLex Volume 4, which contains GMP guidelines applicable to medicinal products. For medicinal products for human use, Volume 4 operates within the broader EU pharmaceutical legal framework and is used by competent authorities for regulation and inspection.

EudraLex Volume 4 is not a single standalone document. It includes Basic Requirements, specialist chapters, and numerous annexes. Important examples include Annex 1 for the Manufacture of Sterile Medicinal Products, Annex 11 for Computerised Systems, Annex 15 for Qualification and Validation, and Annex 16 concerning certification by a Qualified Person and batch release.

PIC/S stands for the Pharmaceutical Inspection Co-operation Scheme. PIC/S is not a global drug licensing authority and it is not a private certification organisation. It is a co-operative arrangement between regulatory authorities designed to promote harmonisation of GMP requirements, inspection standards, inspector training, and information exchange among participating authorities.

The PIC/S GMP Guide is published as PE 009. As of September 2026, the published version is PE 009-17, consisting of an Introduction, Part I, Part II, and Annexes.

The similarity between EU-GMP and PIC/S GMP is not accidental. PIC/S explains that its GMP Guide originally developed from the WHO GMP framework, after which the European Community adopted related principles and both systems continued to develop their GMP guides in close co-operation. When one system modifies its GMP Guide, the other generally works to maintain harmonisation.

For this reason, when an engineer or QA professional compares a chapter of PIC/S PE 009 with the corresponding EU GMP chapter, much of the structure and wording may appear almost identical. However, this does not make EU and PIC/S the same regulatory system. The major differences lie outside the wording of the GMP Guide: who issues it, who enforces it, what legal status it has, and which market requires compliance.

How are EU-GMP and PIC/S GMP different?

The difference can be summarised through one principle: EU-GMP represents GMP within the legal and pharmaceutical regulatory framework of the European Union, while PIC/S GMP is a harmonised GMP guide used to support consistency among participating regulatory authorities. Their technical requirements are highly aligned, but their legal and organisational mechanisms are different.

PIC/S describes its GMP Guide as “equivalent but not identical” to the EU GMP Guide. PIC/S also states that the two documents are maintained in harmony and are practically identical in most areas. One example of a difference is the use of the term “authorised person” in the PIC/S context instead of the EU concept of a “Qualified Person,” along with the removal of references that depend specifically on EU Directives.

This distinction matters when companies compare standards. If the focus is only on requirements for premises, personnel, documentation, production, or quality control, the two systems may look almost the same. However, when the discussion moves to manufacturing authorisation, GMP certificates, the role of the Qualified Person, importation, and placing medicinal products on the EU market, EU-specific legal requirements become decisive.

Therefore, saying that “EU-GMP is higher than PIC/S GMP” is an oversimplification. In many technical areas, there is no clear hierarchy between the two. A more accurate interpretation is that EU-GMP and PIC/S GMP share a deeply harmonised technical foundation but operate within different regulatory and legal frameworks.

How do EU-GMP and PIC/S differ in legal basis and regulatory mechanism?

To understand the difference properly, it is useful to separate two layers: the technical GMP requirements and the regulatory mechanism. At the technical level, EU-GMP and PIC/S GMP are highly similar. At the regulatory level, the differences are much more significant.

EudraLex Volume 4 operates within the pharmaceutical legal and regulatory framework of the European Union. The European Commission describes Volume 4 as containing references to applicable legislation together with guidelines interpreting GMP principles. In other words, the GMP Guide does not exist independently; it forms part of a broader system of legislation, competent authorities, licensing, inspection, and regulatory enforcement.

When a manufacturing site falls within the scope of EU requirements, GMP compliance is connected to the activities of the relevant Competent Authority. A manufacturer is not simply expected to “follow a GMP book.” It must also comply with obligations relating to manufacturing authorisation, inspections, documentation, batch certification, importation, and other market-specific requirements.

PIC/S operates differently. PIC/S membership is held by Regulatory Authorities, not pharmaceutical companies or manufacturing sites. PIC/S explicitly states that companies and individuals cannot become PIC/S members.

This means that a pharmaceutical manufacturer cannot apply directly to PIC/S and request “PIC/S certification.” Instead, the national or regional regulatory authority may become a PIC/S Participating Authority after undergoing an assessment of its GMP inspectorate, legal framework, inspection system, resources, and regulatory capability.

As of September 2026, PIC/S has 57 Participating Authorities. The Jordan Food & Drug Administration became the 57th Participating Authority on January 1, 2026.

Membership of a regulatory authority in PIC/S is meaningful because the authority has undergone an assessment intended to demonstrate that its GMP inspection system is compatible with PIC/S expectations. This promotes confidence between regulatory authorities, facilitates exchange of inspection information, and reduces unnecessary differences in GMP inspection approaches.

However, the fact that a country has a regulatory authority participating in PIC/S does not mean that every pharmaceutical facility in that country automatically “meets PIC/S GMP.” Each manufacturing site must still comply with the requirements of the relevant competent authority and undergo applicable licensing, inspection, or certification processes.

Similarly, a site recognised as GMP-compliant by a PIC/S Participating Authority does not automatically gain access to the EU market. Pharmaceutical market access also depends on marketing authorisation, import requirements, product dossiers, batch certification, and other regulatory obligations.

PIC/S can therefore be understood as a platform that helps regulatory authorities “speak a common GMP language,” while final legal authority remains with the competent authority and the legal system under which the manufacturer operates.

How are the EU GMP Guide and PIC/S GMP Guide structured?

The similarity between the two systems is clearly visible in the structure of their GMP guides. The EU GMP Guide for medicinal products includes Part I on Basic Requirements for Medicinal Products, Part II on Basic Requirements for Active Substances Used as Starting Materials, and a series of specialist annexes. EudraLex Volume 4 also contains additional sections and documents relating to specific manufacturing areas.

Part I includes chapters familiar to most pharmaceutical manufacturers: Pharmaceutical Quality System; Personnel; Premises and Equipment; Documentation; Production; Quality Control; Outsourced Activities; Complaints, Quality Defects and Product Recalls; and Self Inspection.

PIC/S PE 009-17 is also structured into an Introduction, Part I, Part II, and Annexes. This makes it relatively straightforward for multinational companies to use a common Pharmaceutical Quality System across facilities operating in different regulatory regions.

Many annexes also correspond closely. Annex 1 on the Manufacture of Sterile Medicinal Products is one of the clearest examples. Annex 11 on Computerised Systems and Annex 15 on Qualification and Validation are also important references within both frameworks.

However, this similarity does not mean a company should use a PIC/S document and automatically treat it as the legal EU reference. Legal references, terminology, and some annex-related requirements may differ. The EU also includes obligations related to the Qualified Person and other elements specific to its pharmaceutical legal framework.

One example is PIC/S use of the term “authorised person” in certain contexts instead of the EU term “Qualified Person.” PIC/S also removes direct references to EU Directives because those Directives cannot function as common law for non-EU regulatory authorities.

The close structural alignment helps companies build a common GMP foundation, but when preparing for an inspection or market application, the correct version and requirements of the relevant competent authority must still be followed.

Are the core requirements of EU-GMP and PIC/S GMP very different?

At the operational level, the differences are usually much smaller than many first-time users expect. Both systems place the Pharmaceutical Quality System at the centre of GMP. Quality cannot be created only through final product testing; it must be built into the entire manufacturing lifecycle.

Personnel requirements are a good example. Both systems expect manufacturers to have sufficient qualified personnel, clearly defined responsibilities, appropriate training, and systems ensuring that employees performing GMP activities have the necessary knowledge and competence. For high-risk manufacturing such as sterile production, requirements for behaviour, gowning, and operator qualification become even more important.

Premises and Equipment must be designed, arranged, maintained, and cleaned in a manner suitable for their intended use. Facility layout should reduce the risk of mix-ups, contamination, and cross-contamination. The movement of materials, products, waste, and personnel should be logically controlled.

Documentation forms another important control layer. GMP requires critical activities to be described in approved procedures and recorded during execution. Records should make it possible to determine what happened, who performed the activity, when it occurred, and under what conditions. A facility with advanced equipment but weak documentation does not have a strong Pharmaceutical Quality System.

Production must take place according to approved procedures. Starting materials must be controlled. Deviations must be documented and investigated. Yield, reconciliation, and critical process parameters must be managed where appropriate. These principles are fundamentally similar in EU-GMP and PIC/S GMP.

Quality Control is also more than a laboratory conducting final testing. Sampling, specifications, analytical methods, stability testing, and batch release all form part of the product quality system.

Supplier Qualification and Outsourced Activities are increasingly important in a global pharmaceutical supply chain. A manufacturer cannot transfer GMP responsibility to a contractor simply by signing a contract. The company must have systems for qualification, approval, oversight, and ongoing evaluation of outsourced activities that may affect product quality.

Deviation management, CAPA — Corrective and Preventive Action — and Change Control are also common tools of a mature GMP system. When a problem occurs, the objective is not simply to correct the immediate failure but to understand the Root Cause and reduce the likelihood of recurrence.

This explains why a company with a mature Pharmaceutical Quality System built around PIC/S GMP generally does not need to rebuild its entire system when targeting EU-GMP. The critical work is usually a Gap Assessment against EU-specific legal requirements, market expectations, product requirements, and site-specific obligations.

PIC/S maintains GMP harmonisation by developing its Guide in parallel with the EU GMP Guide. Therefore, in many technical areas, the difference is not a fundamentally different “GMP philosophy” but rather detailed implementation, legal context, and regulatory expectations.

Are EU-GMP Annex 1 and PIC/S Annex 1 different?

Annex 1 is one of the clearest examples of co-operation between the EU and PIC/S. The document is titled Manufacture of Sterile Medicinal Products and establishes principles for controlling microbiological contamination, particulate contamination, and endotoxin/pyrogen contamination.

The revised Annex 1 became generally effective on August 25, 2023 in both the EU GMP Guide and PIC/S GMP Guide. PIC/S has confirmed that the PIC/S version of Annex 1 is identical in substance to the EU version apart from minor differences. Paragraph 8.123 had a later implementation date of August 25, 2024.

One of the most important concepts in the current Annex 1 is the CCS — Contamination Control Strategy. Instead of treating cleanrooms, HVAC, cleaning, personnel, environmental monitoring, and equipment as separate systems, manufacturers are expected to identify potential contamination sources and create an integrated strategy linking all control measures.

Quality Risk Management provides the foundation for this approach. An open sterile product operation in Grade A cannot be managed in the same way as handling a closed material in Grade D. The level of control must be proportionate to the severity and likelihood of contamination risk.

Annex 1 also strengthens the role of Barrier Technology. RABS — Restricted Access Barrier Systems — and Isolators help reduce direct interaction between operators and the critical zone. This is significant because personnel remain one of the largest sources of particulate and microbiological contamination in cleanrooms.

Environmental Monitoring is also placed within a broader control system. Particle Monitoring, Viable Monitoring, Personnel Monitoring, and Surface Monitoring are not used only to decide whether a room “passes” or “fails.” They should help manufacturers identify trends and early signs that the system may be moving out of control.

Aseptic Process Simulation — APS — commonly referred to as Media Fill, is used to challenge the entire aseptic process. APS does not compensate for poor design. It is a tool used to periodically confirm that the overall contamination control system continues to perform as expected.

Because the EU and PIC/S developed the revised Annex 1 through close co-operation, a manufacturer operating under PIC/S GMP should not treat EU Annex 1 as an unrelated document. On the contrary, Annex 1 is one of the clearest areas of harmonisation between the two systems.

This also explains why technologies such as isolators, RABS, VHP — Vaporized Hydrogen Peroxide — continuous environmental monitoring, and automation are becoming more important globally rather than only in facilities exporting to the European Union.

How are EU-GMP inspections different from PIC/S GMP inspections?

One of the most common misunderstandings is that PIC/S operates an international inspection team that visits pharmaceutical factories around the world to issue a “PIC/S GMP Certificate.” This is not how PIC/S works.

PIC/S focuses on harmonisation among GMP inspectorates. Membership is available to Regulatory Authorities. PIC/S evaluates authorities applying for participation and carries out extensive training, technical exchange, and development of inspection guidance for GMP inspectors.

Therefore, when a site is inspected using PIC/S GMP principles, the inspection is generally performed by the competent regulatory authority applying PIC/S GMP or an equivalent national GMP framework. The PIC/S Secretariat is not a global certification body for manufacturing facilities.

Within the EU, GMP inspections are performed through the competent authorities of Member States and associated regulatory mechanisms. A GMP Certificate may be issued following an appropriate inspection process, but this is part of the official regulatory system rather than a commercial quality certificate that can be purchased from a private certification company.

This distinction is important for manufacturers evaluating services marketed as “PIC/S certification consultancy.” A consulting company may help a manufacturer prepare its quality system in line with PIC/S GMP Guide expectations, but that is entirely different from an official assessment by a competent regulatory authority.

PIC/S creates significant value at the inspectorate level. When multiple regulatory authorities use compatible GMP principles, training methods, and inspection standards, multinational pharmaceutical companies face a more consistent GMP environment, even though specific legal requirements remain different between countries.

Inspector training is a major part of PIC/S activity. This means harmonisation goes beyond the wording of the GMP Guide. Two authorities may use almost identical GMP requirements, but if their inspectors apply them in very different ways, manufacturers may still experience inconsistent expectations. PIC/S therefore works to harmonise both regulatory systems and inspection capability.

For manufacturers, the practical conclusion is that a facility should not be designed merely to “pass an inspection.” A mature GMP system should be able to explain the logic of its controls and provide evidence of a maintained State of Control regardless of which competent authority conducts the inspection.

Pharmaceutical Quality System, QRM and Data Integrity in both systems

PQS — Pharmaceutical Quality System — is a common foundation of both EU-GMP and PIC/S GMP. GMP compliance is not demonstrated simply by having clean facilities, stainless-steel equipment, and a complete set of SOPs. The more important question is whether the overall system consistently maintains product quality, identifies risk, controls change, and supports continual improvement.

Quality Risk Management — QRM — allows a manufacturer to focus resources on risks that matter most. Instead of applying the same level of control to every activity, QRM evaluates potential impact on product quality, probability of occurrence, and the ability to detect a failure before deciding which controls are appropriate.

Deviation Management is one example. If cleanroom temperature exceeds a limit for several minutes, the manufacturer should not simply record that “temperature returned to normal.” It should evaluate the cause, duration, products potentially affected, severity, history of similar events, and whether CAPA is required.

Change Control is equally important. Replacing a HEPA filter, changing an equipment surface material, modifying a PLC — Programmable Logic Controller — or updating Environmental Monitoring System software may all affect a previously qualified state.

Data Integrity has become increasingly important as pharmaceutical manufacturing depends more heavily on electronic systems. Data must be trustworthy, traceable, protected from inappropriate alteration, and available for review.

ALCOA is a commonly used framework for discussing data integrity: Attributable, Legible, Contemporaneous, Original, and Accurate. ALCOA+ extends the concept with attributes such as Complete, Consistent, Enduring, and Available.

Annex 11 on Computerised Systems is an important reference for GMP electronic systems. Audit Trail, user access control, backup, data retention, system validation, and electronic records may directly affect compliance.

For this reason, moving from a basic domestic GMP framework toward EU-GMP or PIC/S GMP is not merely a cleanroom renovation project. In many facilities, the larger gap lies in Pharmaceutical Quality System maturity, data culture, deviation investigation, CAPA, and Quality Risk Management.

What do EU-GMP and PIC/S GMP require for cleanrooms, equipment, and validation?

Cleanrooms are an important part of many pharmaceutical facilities, but not every GMP area requires the same cleanroom grade. Design should begin with the product, manufacturing process, and contamination risk before determining the required cleanroom grade, airflow, pressure differential, and equipment configuration.

In sterile pharmaceutical manufacturing, Grades A, B, C, and D are used to define environments with different levels of control. Grade A is intended for critical operations where sterile product or critical product-contact surfaces are exposed. Grade B is typically used as the background environment for Grade A in traditional aseptic processing when isolator technology is not used.

HVAC — Heating, Ventilation and Air Conditioning — controls temperature, humidity, air quality, airflow, and pressure cascade. HEPA — High Efficiency Particulate Air — filters are used to reduce particulate concentration in supplied air.

However, installing sufficient HEPA filters does not automatically create a compliant Grade A or Grade B environment. Airflow must be designed to protect critical zones. Airflow Visualization studies help determine whether air movement could carry contamination from personnel, equipment, or less-clean areas toward exposed sterile product.

Material Transfer is another major risk point. Pass Boxes, Material Airlocks, interlock systems, and decontamination technologies may be used to control movement of materials between different cleanroom grades.

Where requirements are higher, VHP Pass Boxes may use Vaporized Hydrogen Peroxide for surface bio-decontamination of suitable materials. However, the equipment only adds value if the cycle is properly designed and validated for the actual load configuration.

RABS and Isolators add another layer of Barrier Technology. Isolators provide a higher degree of separation between personnel and the critical zone and can therefore reduce contamination risk originating from operators. This is why modern aseptic manufacturing projects increasingly consider isolator technology rather than simply increasing the cleanliness level of the entire room.

Qualification is the process of demonstrating that facilities, systems, and equipment are appropriately designed, installed, and operated for their intended use. DQ — Design Qualification — verifies the design against user requirements. IQ — Installation Qualification — confirms correct installation. OQ — Operational Qualification — verifies functions and operating limits. PQ — Performance Qualification — demonstrates performance under actual operating conditions.

Validation extends beyond individual equipment to demonstrate that a process can consistently produce the intended result. Cleaning Validation, Process Validation, Sterilisation Validation, and Computerised System Validation may all form important parts of GMP compliance.

As of September 2026, the EU and PIC/S continue to co-operate on the revision of Annex 15 on Qualification and Validation. A joint EMA–PIC/S drafting group has developed a concept paper for the update of Annex 15, demonstrating that GMP harmonisation between the two systems continues to evolve.

For cleanroom contractors, this has a practical implication: equipment should not be selected only from a catalogue. The design of Pass Boxes, VHP Pass Boxes, FFUs, HEPA Boxes, BIBO systems, or Isolators should be aligned with the URS — User Requirement Specification — and the overall contamination control architecture of the project.

VCR Cleanroom Equipment operates as a supplier of cleanroom equipment for cleanroom contractors. In pharmaceutical projects targeting EU-GMP or PIC/S GMP, equipment such as Pass Boxes, VHP Pass Boxes, FFUs, HEPA Boxes, HEPA/ULPA filters, Dispensing Booths, BIBO systems, and Isolators should be selected according to cleanroom grade, material flow, containment requirements, and the specific control strategy of the project.

Should pharmaceutical companies in Vietnam follow EU-GMP or PIC/S GMP?

There is no single answer that applies to every pharmaceutical manufacturer. The decision should begin with the target market, product type, business strategy, and the regulatory authority that will assess the facility.

If the main objective is to place products on the European Union market, the manufacturer must design its system around applicable EU requirements. PIC/S GMP can provide a highly aligned technical foundation, but “meeting PIC/S GMP” does not automatically grant access to the EU market. EU requirements relating to legal authorisation, marketing authorisation, manufacturing and importation, batch certification, and release still apply.

If a manufacturer targets multiple markets regulated by PIC/S Participating Authorities, building a Pharmaceutical Quality System aligned with the PIC/S GMP Guide can provide a strong international foundation. As of September 2026, PIC/S has 57 Participating Authorities, demonstrating the broad global reach of the network.

However, PIC/S participation does not create a single unified “PIC/S pharmaceutical market.” Australia, Singapore, Japan, Canada, and European authorities may all participate in PIC/S, yet each jurisdiction maintains its own pharmaceutical laws, registration procedures, and market-specific requirements.

For manufacturers of sterile medicinal products, Annex 1 should be treated as a central reference regardless of whether the project is initially framed around EU-GMP or PIC/S GMP. CCS, Grades A/B/C/D, environmental monitoring, aseptic behaviour, Barrier Technology, and APS all have a direct impact on facility design.

For biotechnology, vaccines, and advanced therapies, manufacturers may also need to consider closed processing, Single Use Systems, biosafety, and product-specific requirements. Asking only “Which cleanroom grade do we need?” is not sufficient to define the entire GMP strategy.

For API — Active Pharmaceutical Ingredient — manufacturing, the focus may shift more toward Part II, ICH Q7, and the requirements of the target market. An API manufacturing facility has a substantially different risk profile from an aseptic filling facility.

CMOs — Contract Manufacturing Organisations — and CDMOs — Contract Development and Manufacturing Organisations — often serve multiple customers and markets. In these cases, designing the facility and quality system around the highest relevant requirements from the beginning may be more efficient than repeatedly upgrading the site for individual clients.

A practical decision framework can be summarised as follows:

One costly mistake is to build a facility around the minimum current requirement and only later decide to target a more demanding market. At that stage, changes to layout, HVAC, airlocks, material flow, or barrier technology may become extremely expensive.

For new projects, market strategy should therefore be defined before Design Qualification. If the company may target the EU in the future, incorporating important EU-GMP expectations into the URS from the beginning can significantly reduce future upgrade costs.

Common misunderstandings about EU-GMP and PIC/S GMP

The first common misunderstanding is that “EU-GMP is much higher than PIC/S GMP.” PIC/S states that its GMP Guide is maintained in harmony with the EU GMP Guide and that much of the content is practically identical. The major difference lies more in legal context and enforcement than in fundamentally different GMP principles.

The second misunderstanding is that “PIC/S is an international certificate.” PIC/S is a co-operation scheme between Regulatory Authorities, not a certification body for pharmaceutical companies. A company cannot become a PIC/S member, and the PIC/S Secretariat does not directly issue GMP certificates to manufacturing sites.

The third misunderstanding is that “if a country joins PIC/S, all pharmaceutical manufacturers in that country automatically comply with PIC/S GMP.” Membership belongs to the regulatory authority, not to every manufacturing facility. Each site must still comply with the requirements of the competent authority.

The fourth misunderstanding is that “PIC/S GMP compliance automatically allows export to the EU.” GMP compliance is only one part of market access. The EU also has requirements relating to marketing authorisation, importation, Qualified Person responsibilities, batch certification, and other legal obligations.

The fifth misunderstanding is that “EU-GMP is mainly a cleanroom standard.” Cleanrooms are highly important for many pharmaceutical products, but EU-GMP also covers Pharmaceutical Quality Systems, personnel, documentation, production, Quality Control, supply chains, CAPA, Change Control, and many other areas.

The sixth misunderstanding is that “a cleanroom meeting ISO 14644 automatically meets EU-GMP or PIC/S GMP.” ISO 14644 plays an important role in cleanroom classification and control, but it does not cover the complete GMP system. A room may meet the required ISO Class while still failing GMP expectations for aseptic processes, personnel, or environmental monitoring.

The seventh misunderstanding is that “Annex 1 is only a table of Grades A, B, C, and D.” The current Annex 1 places substantial emphasis on CCS, QRM, Barrier Technology, environmental monitoring, aseptic processing, and multiple integrated contamination-control layers.

The eighth misunderstanding is that “buying an isolator or VHP Pass Box is enough to comply with Annex 1.” Equipment is only one layer of control. If the transfer process is poorly designed, the VHP load is not validated, or operator practices are weak, advanced equipment alone cannot create compliance.

The final misunderstanding is that “Validation only needs to be performed once when the facility is built.” GMP requires the validated state to be maintained throughout the lifecycle of the system. Changes, maintenance, adverse trends, and long-term operation may require requalification or revalidation.

FAQ — Frequently Asked Questions about EU-GMP and PIC/S GMP

Question: What is EU-GMP?

EU-GMP refers to Good Manufacturing Practice principles and guidelines within the pharmaceutical regulatory system of the European Union. EudraLex Volume 4 is a central GMP reference and includes Basic Requirements and specialist Annexes for specific areas of pharmaceutical manufacturing.

Question: What is PIC/S GMP?

PIC/S GMP generally refers to the PIC/S GMP Guide PE 009 maintained by the Pharmaceutical Inspection Co-operation Scheme. The guide supports harmonisation of GMP requirements among participating Regulatory Authorities.

Question: What is the main difference between EU-GMP and PIC/S GMP?

The main difference lies in legal basis and regulatory application. EU-GMP operates within the EU pharmaceutical regulatory framework, while PIC/S GMP supports harmonisation between regulatory authorities. The technical content of the two GMP Guides is highly aligned.

Question: Which is higher, EU-GMP or PIC/S GMP?

They should not be ranked simply as higher and lower standards. PIC/S states that its GMP Guide is equivalent but not identical to the EU GMP Guide. The requirements that matter depend on the product, competent authority, and target market.

Question: Is PIC/S GMP the same as EU-GMP?

The two GMP Guides are highly similar and are maintained in harmony, but they are not completely identical. Differences may exist in terminology, legal references, and requirements connected to each regulatory system.

Question: Does PIC/S directly certify pharmaceutical manufacturers?

No. PIC/S is not a manufacturing-site certification authority. PIC/S members are Regulatory Authorities. GMP inspections and certification are performed by the competent authorities responsible for the relevant market or jurisdiction.

Question: Can a pharmaceutical company become a PIC/S member?

No. PIC/S membership is available only to Regulatory Authorities. Companies and individuals cannot become PIC/S members.

Question: What does it mean when a country is part of PIC/S?

More precisely, a regulatory authority from that country or jurisdiction is a PIC/S Participating Authority. This indicates that the inspectorate has undergone PIC/S assessment, but it does not mean that every pharmaceutical manufacturer in the country automatically meets GMP.

Question: How many PIC/S Participating Authorities are there?

As of September 2026, PIC/S has 57 Participating Authorities. The Jordan Food & Drug Administration became the 57th Participating Authority on January 1, 2026.

Question: Does PIC/S GMP compliance automatically allow a manufacturer to export medicines to the EU?

No. GMP compliance does not automatically grant EU market access. Manufacturers must also comply with requirements relating to marketing authorisation, manufacturing and importation, batch certification, release, and other applicable EU pharmaceutical regulations.

Question: Are EU-GMP Annex 1 and PIC/S Annex 1 the same?

The two versions were developed through close co-operation and are essentially aligned. PIC/S confirms that its Annex 1 has the same substantive content as the EU version, with only minor differences.

Question: Are Grades A, B, C, and D used in PIC/S GMP?

Yes. PIC/S Annex 1 uses Grades A, B, C, and D for sterile medicinal product manufacturing environments, in alignment with EU-GMP Annex 1.

Question: Does an ISO 14644-compliant cleanroom automatically comply with EU-GMP?

No. ISO 14644 focuses on cleanrooms and controlled environments, including airborne particle classification. EU-GMP covers the complete manufacturing system, including personnel, microbiology, procedures, documentation, validation, and the Pharmaceutical Quality System.

Question: Should a pharmaceutical company in Vietnam follow EU-GMP or PIC/S GMP?

The decision should begin with the target market. If the company intends to export to the EU, applicable EU requirements must be incorporated into facility design and the Pharmaceutical Quality System. PIC/S GMP can provide a strong international foundation, but market-specific requirements still need to be assessed.

Question: Which PIC/S GMP Guide version is current?

As of September 2026, the PIC/S Publications system lists PIC/S GMP Guide PE 009-17, including the Introduction, Part I, Part II, and Annexes.

Question: Is Annex 15 on Qualification and Validation being revised?

Yes. In 2026, a joint EMA–PIC/S drafting group developed a concept paper for the revision of Annex 15 on Qualification and Validation. This demonstrates that the EU and PIC/S continue to co-operate in the development of GMP guidance.

Conclusion

EU-GMP and PIC/S GMP should not be viewed as two GMP levels placed on the same ladder where one is simply “higher” than the other. Most of the technical requirements in the two GMP Guides are deeply harmonised and highly similar. The more important differences lie in legal origin, regulatory authority, inspection mechanisms, and the market in which the medicinal product will be supplied.

EU-GMP operates within the pharmaceutical legal and regulatory system of the European Union. PIC/S, by contrast, creates a common platform that helps Regulatory Authorities around the world harmonise GMP expectations and inspection capability. This gives PIC/S influence far beyond Europe, but it does not replace the pharmaceutical law of individual markets.

For pharmaceutical manufacturers, the maturity of the Pharmaceutical Quality System is more important than the label placed on the standard. A facility must be capable of managing risk, controlling contamination, protecting data integrity, investigating deviations, implementing CAPA, managing change, and maintaining the validated state throughout the lifecycle of the facility.

For sterile medicinal product manufacturing, these requirements become even more demanding. Annex 1 means that a cleanroom cannot be treated as an isolated construction package. Cleanroom Grade, HVAC, HEPA filtration, airlocks, personnel flow, material flow, RABS, Isolators, VHP, Environmental Monitoring, and Validation should all be connected through a CCS — Contamination Control Strategy.

For this reason, a pharmaceutical project targeting EU-GMP or PIC/S GMP should not begin by asking how many pieces of equipment need to be purchased. It should begin with the product, process, contamination risks, and target-market requirements. Once these factors are clearly defined, the cleanroom contractor can determine the appropriate room classification and equipment configuration.

VCR Cleanroom Equipment is a supplier of cleanroom equipment for cleanroom contractors, providing product groups such as Pass Boxes, VHP Pass Boxes, Air Showers, FFUs, HEPA Boxes, HEPA/ULPA Filters, Clean Booths, Dispensing Booths, BIBO systems, Isolators, and other specialised cleanroom control equipment.

For pharmaceutical projects targeting EU-GMP, PIC/S GMP, or high-level sterile manufacturing requirements, cleanroom contractors can contact VCR Cleanroom Equipment for support in selecting equipment configurations appropriate for the required cleanroom grade, technical specifications, material flow, and specific project conditions.

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