Good Manufacturing Practice (GMP) is the set of controls that makes sure every batch is made the same way, in clean conditions, by trained people, with records to prove it. Buyers, regulators and export markets ask for it in different forms. A pharmaceutical plant needs GMP to keep its DRAP manufacturing licence, a cosmetics exporter may be asked for ISO 22716, and a food factory needs GMP as the foundation of HACCP. This guide explains which GMP applies to your industry in Pakistan and how to prepare for an audit.
Quick answer: GMP certification confirms that a manufacturing facility follows recognised good manufacturing practice for premises, equipment, hygiene, personnel, production, quality control and documentation. In Pakistan, GMP is mandatory for pharmaceutical and other DRAP-regulated manufacturers and is checked through DRAP inspections. For food and cosmetics, GMP is usually certified voluntarily by an accredited certification body, for example against ISO 22716 for cosmetics or as part of food safety schemes, often because buyers or export markets require it.
Which GMP applies to your product?
| Sector | GMP framework | Who checks it |
|---|---|---|
| Pharmaceuticals and DRAP-regulated products | DRAP GMP requirements aligned with WHO GMP | DRAP inspectors, as a condition of the manufacturing licence |
| Cosmetics and personal care | ISO 22716 Cosmetics GMP | Accredited certification bodies; required by many export buyers |
| Food and beverages | GMP and prerequisite programmes, for example ISO/TS 22002-1 and Codex hygiene principles | Food authorities during licensing and inspection; certification bodies within ISO 22000 or FSSC 22000 |
| Packaging for food and pharma | Packaging hygiene and GMP standards | Certification bodies and customer audits |
Not sure which regulator owns your product? Our DRAP classification guide explains how to tell a drug, health product or cosmetic apart.
GMP vs HACCP vs ISO 22000
These are often confused. GMP covers the basic conditions of manufacturing: building, cleaning, pest control, staff hygiene and documentation. HACCP is a method for identifying and controlling specific food safety hazards at critical points. ISO 22000 is a full food safety management system that includes both. In practice, GMP comes first: a HACCP plan built on a dirty or poorly controlled factory will fail. For the management-system route, see our guide to ISO 22000 and HACCP certification.
What a GMP audit looks at
- Premises and layout: logical flow of materials and people, segregation of raw, in-process and finished goods, washable surfaces, ventilation and lighting
- Equipment: suitable materials, cleaning and maintenance schedules, calibrated instruments
- Personnel: training records, health checks, hygiene rules, protective clothing
- Sanitation and pest control: written cleaning procedures, records, approved chemicals and a pest control contract
- Materials: supplier approval, incoming inspection, storage conditions and stock rotation
- Production: batch manufacturing records, line clearance, in-process checks and labelling control
- Quality control: a lab for release testing, specifications, retained samples and stability data
- Documentation: controlled SOPs, change control, deviation handling, complaints and recalls
How to prepare for GMP certification
- Gap assessment against the relevant GMP standard, covering premises, documentation and practice on the floor.
- Fix the facility first. Layout, drainage, finishes and air handling are hard to change later, so plan them before writing SOPs.
- Write and implement SOPs for cleaning, hygiene, production, QC, storage and recalls, then train staff on them.
- Generate records. Run the system long enough to show consistent batch records, cleaning logs and QC results.
- Internal audit and mock inspection to find and close remaining gaps.
- Certification or regulatory audit by the certification body or DRAP, followed by corrective actions.
- Maintain. Surveillance audits and regulatory inspections continue, so GMP has to be part of daily operations.
Common GMP failures in Pakistani plants
- Batch records completed after production instead of during it
- Cleaning done but not recorded, or recorded but not validated
- No segregation between raw materials and finished goods in the store
- QC lab equipment without current calibration
- Temporary staff working without hygiene training
Many of these problems start at the design stage. Our article on why cosmetic formulas fail at production scale covers the process side, and our QC laboratory reference covers the testing side.
Frequently asked questions
Is GMP certification mandatory in Pakistan?
GMP is mandatory for pharmaceutical and other DRAP-regulated manufacturers as a condition of their licence. For food and cosmetics, formal GMP certification is usually voluntary but is often required by buyers, retailers and export markets.
What is ISO 22716?
ISO 22716 is the international guideline for good manufacturing practice in cosmetics. It covers production, control, storage and shipment of cosmetic products and is widely requested by export buyers.
What is the difference between GMP and HACCP?
GMP sets the basic hygienic and operational conditions for manufacturing. HACCP identifies and controls specific food safety hazards. GMP is a prerequisite for an effective HACCP system.
Who issues GMP certificates in Pakistan?
DRAP inspects pharmaceutical manufacturers for GMP compliance. For food and cosmetics, accredited certification bodies issue GMP certificates after an audit.
How long does it take to prepare for a GMP audit?
It depends on the condition of the facility. A plant that needs layout changes takes longer than one that mainly needs documentation, because auditors expect to see operating records, not just written procedures.
How CEC can help with GMP
Connect Engineers & Consultants carries out GMP gap assessments, advises on plant layout, writes SOPs and batch records, trains staff and prepares food, cosmetics and pharmaceutical manufacturers for certification and DRAP inspections. Explore our certification services.
Facing a buyer audit or DRAP inspection? Book a GMP gap assessment before the auditor arrives.
GMP requirements differ by product and regulator and are updated over time. Confirm the applicable standard with DRAP, your food authority or your certification body. This guide is general information, not legal or tax advice.
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