Stakeholder Comments are invited on draft guidance for Categorization of deficiencies in Good Manufacturing Practices (GMP)

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a comprehensive guidance to the inspectors for categorizing the GMP non-compliances found during inspections. This document is intended to inform stakeholders regarding the principles used to classify GMP deficiencies and provide examples of the classification of different types of deficiencies.

The key objectives of categorizing the GMP non-compliances during report writing are:-

The harmonization of the classification of GMP deficiencies to facilitate synchronized reporting of GMP deficiencies from inspections across the inspectorate. Harmonization will help ensure that there is a consistent view across the inspectorate of what constitutes a “Critical” deficiency and what constitutes a “Major” deficiency. Risk management principles will be applied to the categorization of these deficiencies dependent on the type of product manufactured or process.

This guidance document is also intended to:

  1. provide actions to be taken by inspectorates in response to the reporting of critical and major deficiencies;
  2. enhance communication, information sharing and scientific exchange to promote increased consistency and predictability in regulatory
  3. to provide a tool to support the risk-based classification of GMP deficiencies from inspections and to establish consistency amongst Inspectorates.

This guidance will enable Industry to be informed of the principles used to classify GMP deficiencies and also provide examples of the classification of
different types of deficiencies. Notwithstanding, this approach is not binding as the classification takes also into account the context of the finding and the quality history of the site. It does not remove the responsibility of the company in assessing the impact of he finding on the products already on the market and/or on their quality system.

Consistency of classification of GMP deficiencies will assist in the following:

  1. Improve consistency in reporting and facilitate communication between inspectors;
  2. Harmonize inspectorate response and management of deficiencies classified as “Critical”, “Major” and “Other”;
  3. Provide transparency in how the deficiencies are classified; and
  4. Simplify deficiency trend analysis based on harm

This draft guideline is uploaded on the official website of DRAP dated 28th May, 2022, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to ajmal.sohail@dra.gov.pk, copying at hasan.afzaal@dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the Draft Guidance on categorization of deficiencies in GMPDownload