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Stakeholder Comments are invited on draft guidance for Categorization of deficiencies in Good Manufacturing Practices (GMP)

Ijaz Mustafa Drugs ,

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

DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country

Asad Ullah News & Updates, Publications, Regulatory Updates

DRAP has a regulatory oversight on import and export of all type of therapeutic goods to determine whether they are permittable in accordance with the applicable drug laws, and refuses the entry or exit of any therapeutic good in case of noncompliance to the regulatory requirements.

“Import and export of any therapeutic goods prohibited under Rule 23 of the Drugs Act 1976 and Schedule II of the DRAP Act 2012 are punishable under Rule 27 of the Drugs Act 1976 and Schedule III of the DRAP Act, 2012”

These regulatory controls are applied to prevent the infiltration of substandard and suspected falsified medicine into the supply system and to assure the access to standard quality therapeutic goods. This guidance document will elaborate the requirements, procedures for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. It covers the both import and export of therapeutic goods for commercial and non-commercial purposes, and also provides guidance on determination of the eligibility of importers and exporters.

Please click to access the final guidance document on “Import and Export of Therapeutic Goods“

The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods. These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP.

For more information on regulatory guidelines issued by DRAP, please navigate to our section on “Regulatory Guidelines“