PIC/S GMP in Pakistan: DRAP’s phased plan and the road to membership
DRAP has made PIC/S GMP its inspection reference and is phasing in the chapters. Pakistan is not yet a PIC/S member. Here is where things stand.
In this article
Meeting international good manufacturing practice is the gateway to regulated export markets, and Pakistan’s regulator has started to move its inspections onto the PIC/S standard.
The phased plan
| Date | Step |
|---|---|
| August 2025 | SRO 1587(I)/2025 makes the PIC/S GMP Guidelines the reference standard for DRAP inspections |
| 23 February 2026 | The Central Licensing Board approves the phased plan at its 314th meeting |
| 25 February 2026 | Phase one: Chapter 4 (documentation) applies to manufacturers |
| 1 June 2026 | Site Master File and Technical Agreements enforced |
Other chapters are temporarily exempted, with dates to follow a review of industry preparedness and regulatory capacity, The News reported in February 2026. The Central Licensing Board also approved an interim compliance framework for new units covering premises, equipment, production and quality control, hygiene and manufacturing records. A DRAP circular said future inspections and licensing decisions will be guided by the PIC/S-aligned standards.
Membership and international recognition
Pakistan is not yet a PIC/S member. In June 2026, the International Council for Harmonisation (ICH) designated DRAP as an Observer, APP reported. Health Minister Syed Mustafa Kamal said he hoped for closer engagement with PIC/S, and the government pledged support for DRAP to reach and maintain WHO Global Benchmarking Tool Maturity Level 3.
What PIC/S is
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a co-operation between regulatory authorities’ GMP inspectorates. Its members are regulators, not companies. They share a common GMP guide, train inspectors together and rely on each other’s inspection standards. A country joins only after its inspectorate has been assessed against PIC/S requirements — a process that usually takes several years. For industry, membership matters because it signals to other regulators and buyers that a country’s GMP inspections meet an international standard.
How the GMP guide is organised
The main part of the PIC/S GMP Guide, for finished medicines, has nine chapters:
| Chapter | Subject |
|---|---|
| 1 | Pharmaceutical quality system |
| 2 | Personnel |
| 3 | Premises and equipment |
| 4 | Documentation |
| 5 | Production |
| 6 | Quality control |
| 7 | Outsourced activities |
| 8 | Complaints and product recall |
| 9 | Self-inspection |
A second part covers active pharmaceutical ingredients, and annexes deal with specific topics such as sterile manufacturing (Annex 1), computerised systems and qualification and validation.
Why documentation comes first
DRAP’s choice to start with Chapter 4 is logical: every other chapter depends on good documentation. Specifications, procedures, batch records and logbooks are how a manufacturer proves that it did what it said it would do. Modern documentation expectations also include data integrity — records must be attributable, legible, contemporaneous, original and accurate, whether on paper or in a computer system.
The Site Master File, enforced from June 2026, is a document describing a manufacturing site: its activities, premises, equipment, quality system and personnel. Technical agreements set out who is responsible for what when work is outsourced — for example, when one company manufactures for another or a laboratory tests on a manufacturer’s behalf. Both make inspections faster and responsibilities clearer.
Preparing for the next chapters
Other chapters will follow once DRAP has reviewed industry readiness. Manufacturers do not need to wait for those dates to prepare. A gap assessment against the full PIC/S guide, a prioritised improvement plan and a budget for the larger items — premises, HVAC, water systems and laboratory equipment — will make each new phase easier to absorb. Plants that aim to export will need to meet the whole guide anyway.
What manufacturers are investing in
- Documentation and quality systems, the first chapter to apply
- Cleanrooms, HVAC and water systems that meet PIC/S expectations
- Validation, QC laboratories and data integrity
Suppliers of all three exhibit at Pharma Asia 2026, and PIC/S compliance was a full day of the 2025 convention.
