Asia-Pacific Roundup: Pakistan finalizes GMP guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing a draft document last month.
 
While most of the final document remains unchanged from the earlier draft, DRAP made extensive revisions to the quality control requirements, rewriting and expanding its original stance and bringing its GMP rules into one document for the first time.
 
The final guidelines clarify that licensed companies need adequate facilities, trained personnel and approved procedures for sampling, inspecting and testing ingredients and finished products, as well as possess validated test methods and retain enough of their starting materials and products to “permit future examination.” DRAP has also added details on other basic quality control requirements that companies must meet.
 
Significant revisions were made to the control procedures subsection too. DRAP has provided information on the need to label samples with certain information and added lists of test requirements for starting and packaging materials, in-process control and finished products. The finished product section states that manufacturers can revalidate products that fail to meet established specifications and reject them if they fail again. Reprocessing is acceptable, provided the reprocessed product meets all specifications.
 
DRAP’s advice on control procedures now features discussions of production record and batch review and stability studies. The guidelines state that manufacturers must review production and control records and “thoroughly” investigate divergences or failures to meet batch specifications. On stability studies, DRAP is asking manufacturers to develop written programs for ongoing stability determination.
 
Subsections on self-inspection, quality audits, complaints and product recalls have been added, although the recall subsection reuses some text from the original draft. DRAP expects GMP manufacturers to “conduct repeated self-inspection” to evaluate compliance with all aspects of the production and quality control requirements, detect shortcomings and recommend corrective actions. As well as routine inspections performed at least once a year, companies can run ad-hoc self-inspections, for example, in response to a recall.

(Source: Regulatory Focus)