GMP certification in Pakistan, and who can actually issue one

What is GMP, and is there a single GMP standard?

No. There is no single international GMP standard in the way there is a single ISO 9001. There are several regimes that agree on principles and differ in detail, and which one matters to you depends on where your product is made and where it is going.

The World Health Organization version is the basis for national rules in well over a hundred countries, and it is the reference point most developing market regulators built from. The European Union writes its own, the United States writes its own in regulation, and a group of inspectorates maintains a harmonised guide so that an inspection in one member country means something in another.

The practical consequence is that a plant built to satisfy DRAP is not automatically a plant that satisfies a European or American inspector, and a plant built to satisfy a European inspector will comfortably satisfy DRAP. If export is the goal, build to the higher bar once rather than twice.

Who can actually issue a GMP certificate in Pakistan?

For medicines, the regulator. GMP status is established by inspection, and the document that follows is the regulator's, not a private body's.

This matters because the market is muddled on the point. There is no accredited GMP certification scheme in the sense that ISO 9001, ISO 22000 or ISO 13485 certification is accredited, where an accreditation body stands behind a certification body which stands behind your certificate. GMP sits outside that structure. When a private firm issues a document with the word GMP on it, that document is the opinion of the firm that wrote it, and its value is whatever the reader thinks the firm's name is worth.

Sometimes that is worth quite a lot. A buyer in a market that cannot send its own auditors may reasonably accept a respected third party's audit report. We help clients commission exactly that when it serves a purpose. What we will not do is call it a GMP certificate, because the word misleads the person who reads it next.

One small detail that confuses people, worth clearing up: DRAP itself holds an ISO 9001:2015 certificate. That covers DRAP's own internal quality management as an organisation. It says nothing about your plant and it is not a GMP scheme.

What does DRAP inspect you against?

Against the schedules named above, read together with your licence and your product registrations. In practice an inspection is not a document review, it is a walk through the plant with the documents in hand, and the gap between what your procedures say and what your staff actually do is where findings come from.

The areas that generate findings most reliably, in our experience, are the unglamorous ones. Water systems and their qualification. Cleaning validation, and whether you can prove the cleaning works rather than assert it. Environmental monitoring in areas that need it. Batch record completeness, including the corrections people make in the moment. Change control, which almost every plant underuses. Deviation handling, and whether deviations get investigated or just recorded. Qualification and calibration of the equipment the batch depends on. Training records that correspond to what the person actually does.

None of that is exotic. It is simply the difference between a plant that runs on a system and a plant that runs on the memory of three experienced people, which is the position a great many otherwise capable Pakistani manufacturers are in.

What are the five manufacturing licence types?

The Drugs (Licensing, Registering and Advertising) Rules, 1976 provide five types of drug manufacturing licence. Knowing which one you hold or need matters, because the GMP expectations and the capital involved differ sharply between them.

A licence runs for five years unless it is revoked or suspended earlier, so renewal is a recurring event rather than a one off hurdle, and the condition of your quality system at renewal is what the renewal turns on.

Is Pakistan a PIC/S member, and why does that matter?

This is the fact that changes how a Pakistani exporter should think about GMP, and almost nobody states it plainly.

The Pharmaceutical Inspection Co-operation Scheme is how regulators recognise each other's inspections. If your regulator is a participating authority, a GMP inspection at home carries weight abroad. DRAP is not a PIC/S participating authority. It is also not listed as an applicant, nor as a pre-applicant. Pakistan is simply absent from the scheme.

India and Bangladesh are not participating authorities either, so this is a regional pattern rather than a uniquely Pakistani problem. But it has a direct commercial consequence: when your buyer or their regulator cannot lean on your regulator's inspection, they ask you to supply the assurance yourself. That is why Pakistani exporters get asked for WHO GMP style evidence, third party audit reports, buyer audits and documentation packs that a Malaysian or Turkish manufacturer is not asked for.

So the practical answer to a Pakistani pharmaceutical exporter is: build the quality system to a standard that stands on its own, because your regulator's signature will not carry it for you.

What does GMP work cost in Pakistan?

There is no fixed price. The range between a small formulation plant tidying up an existing system and a site preparing for a demanding export inspection is wide enough that any single figure is meaningless.

Axora Global quotes a consultancy fee band after a free gap analysis, once the scope, your number of sites and the maturity of your existing system are known, and arranges any independent audit separately. For GMP there is an important addition: we will tell you before you spend anything whether the gap is a documentation gap or a capital gap. A documentation gap is consultancy work. A capital gap, for example a water system that cannot be qualified or an area that cannot hold its classification, is construction and equipment, and no amount of paperwork closes it. Finding that out at the start is worth more than anything else in the engagement.

How long does it take to get a site GMP ready?

For a working plant that needs its system brought into order, three to six months is realistic. For a plant with physical deficiencies, the timeline is set by the construction and qualification work, not by us, and twelve to eighteen months is common. For a new site, GMP readiness should be designed in from the drawings, and retrofitting it afterwards is the most expensive way to arrive at the same place.

What stretches a timeline is almost always validation and qualification. Cleaning validation needs runs. Process validation needs batches. Stability needs time that cannot be compressed. A plan that ignores those is not a plan.

What about GMP outside medicines?

Several of our clients come to us for GMP and turn out to need something adjacent, which is usually cheaper and more certifiable.

Food. Good manufacturing practice in food is normally handled as part of the prerequisite programmes underneath a food safety management system. If a buyer is asking a food business for GMP, what they generally want is HACCP, ISO 22000 or a GFSI recognised scheme such as FSSC 22000 or BRCGS, all of which are properly certifiable. We would usually steer a food manufacturer there rather than towards a standalone GMP document.

Cosmetics. ISO 22716:2007 covers good manufacturing practices for cosmetics. It was confirmed as current in 2022 and remains in its 2007 edition. One thing to know about it: ISO wrote it as guidelines rather than as a requirements standard. That is why audits against it vary in what they actually test, and why you should ask what a cosmetics GMP audit will cover before you buy one.

Dietary supplements. The United States has run a separate current good manufacturing practice regime for dietary supplements since 2007, distinct from the rules for medicines. If you export supplements rather than medicines, that is the regime to read.

Medical devices. Device quality systems moved away from the GMP framing and towards ISO 13485 some time ago, and since February 2026 the American rules are built on ISO 13485:2016 itself. If devices are your business, that is the page to read rather than this one.

How we work on GMP

The gap analysis is free and it is a site visit, not a sales call. We walk the plant, read what you have, and come back with a written list separating the documentation gaps from the capital gaps, with the sequence and the honest view of how long each takes. You keep that document whether or not you engage us.

After that the work is unglamorous and specific: the quality system documents built around your actual process, validation and qualification plans that can be executed with the equipment you own, deviation and change control that people will really use, training that matches the job, and a mock inspection before the real one. We prepare you for the regulator's inspection, and where a buyer wants independent evidence we arrange an audit by a third party whose name carries weight in your market.

We do not issue GMP certificates, because for medicines nobody outside the regulator can.