What is PIC/S GMP?

What is PIC/S GMP? What do PIC/S GMP guidelines include? What are the mission and value of PIC/S GMP? This article will address the basics of PIC/S GMP. Let's get into it!

1. What is PIC/S GMP?

PIC/S GMP definition

PIC/S GMP is Good Manufacturing Practices guidelines of medicinal products, formulated by PIC/S (Pharmaceutical Inspection Co-operation Scheme).

PIC/S GMP is meant as guidelines to improve cooperation in the field of Good Manufacturing Practices between Regulatory Authorities and the pharmaceutical industry

PIC/S organization

A Committee of the Participating Authorities’ representatives (PIC/S Committee) supervises the operation of the Pharmaceutical Inspection Co-operation Scheme

There are more than 50 PIC/S participating authorities from all over the world.

Europe 33 countries: 1-Austria, 2-Belgium, 3-Cyprus, 4-Czech Republic, 5-Denmark, 6-Estonia, 7-Finland, 8-France, 9-Germany, 10-Greece, 11-Hungary, 12-Iceland, 13-Ireland, 14-Israel, 15-Italy, 16-Latvia, 17-Liechtenstein, 18-Lithuania, 19-Malta, 20-Netherlands, 21-Norway, 22-Poland, 23-Portugal, 24-Romania, 25-Slovak Republic, 26-Slovenija, 27-Spain, 28-Sweden, 29-Switzerland, 30-Ukraine, 31-United Kingdom, 32-Croatia, 33-Turkey.

Asia 09 countries: 1-Taiwan, 2-Malaysia, 3-Indonesia, 4-Singapore, 5-Korea, 6-Hong Kong, 7-Japan, 8-Thailand, 9-Iran,

Australia 02 countries: 1-Australia, 2-New Zealand

Africa 01 country: South Africa

Americas 05 countries: 1-United States, 2-Canada, 3-Argentina, 4-Brazil, 5-Mexico

PIC/S-GMP and EU-GMP are the highest quality standards for pharmaceutical production systems. PIC/S GMP will help remove trade barriers between countries participating in the PIC/S association.

Vietnam is currently pursuing the goal of becoming a member of PIC/S-GMP. Many pharma manufacturers have met GMP standards, especially EU GMP. However, to obtain PIC/S-GMP, domestic companies need to be ready in terms of both human and material resources.

2. PIC/S GMP guidelines

Sections of PIC/S GMP guideline

PIC/S GMP is divided into 2 parts with appendixes
Part I: Manufacturing principles
Part II: Standards for specific medicine types

Details of PICS GMP

About PE009-14
Quality Management (Chapter 1)
Personnel (Chapter 2)
Premises and equipment (Chapter 3)
Documentation (Chapter 4)
Production (Chapter 5)
Quality Control (Chapter 6)
Outsourced activities (Chapter 7)
Sterile medicinal products (Appendix 1)
Pharmaceutical substances and biological products for human use (Appendix 2)
Radiopharmaceuticals (Appendix 3)
Medicinal gas (Appendix 6)
Herbal medicinal products (Appendix 7)
Sampling of starting and packing materials (Annex 8)
Computerized system (Appendix 11)
Investigational medicinal products (Appendix 13)
Qualification and validation (Appendix 15)
Real-time release testing and parametric release (Appendix 17)
Samples for reference and retention (Appendix 19)

You can download the full English version of this PICS GMP guidelines here

3. The role and significance of the PIC/S GMP

Purpose and role of PICS GMP

The purpose of PIC/S GMP is to create common standards in good manufacturing practice for pharmaceutical products with specific roles as follows:

• The highest quality standards are maintained in pharmaceutical research, development, production, and quality control.
• Uniformity in licensing for manufacturing facilities.
• Uniformity and consistency in inspection and testing.
• Barriers to the removal of pharmaceutical trade between countries and regions.

PICS GMP activities

PIC/S aims to lead the international development, implementation and maintenance of GMP standards and the quality system of inspection bodies in the field of human and animal medicines. That would be achieved by:

• Harmonizing by developing and promoting GMP standards and guidance documents
• Providing training courses to national regulatory agencies, especially GMP inspectors
• Evaluating and re-evaluating inspectors
• Facilitating cooperation and networking for regional and international organizations

Benefits of PICS GMP

PICS membership brings great benefits to countries. Some of the benefits we can mention are as follows:

• Improvement in the capacity of the management agencies, regularly receive training, exchange information and management experience.
• Cost-savings in inspection and testing, avoiding duplicate inspection and testing.
• Distribution network expansion
• Pharmaceutical quality warranty, creating trust for partners and consumers.
• Especially in Vietnam, companies and enterprises that own production lines meeting PIC/S GMP standards will have the advantage of bidding for group 2 in the group of generic drugs for distribution to hospitals and public clinics. This is a huge advantage for factories that meet this standard.

4. PIC/S-GMP and EU-GMP certified pharma companies

Since 2015, the Ministry of Health of Vietnam has encouraged domestic pharmaceutical companies and factories to conform to PIC/S GMP standards in manufacturing processes. With the goal that after 6 years, Vietnam will become an official member of PIC/S.

However, due to the large initial investment cost, long construction time, there are not many pharmaceutical manufacturing facilities that meet PIC/S GMP in Vietnam.

Below is an updated list of PIC/S-GMP-certified and EU-GMP-certified manufacturing facilities (Batch 72) according to Official Dispatch No. 3517/QLD-CL dated April 9, 2020, sent by the Drug Administration of Vietnam.

PIC/S-GMP-certified and EU-GMP-certified manufacturing facilities

See also: What is EU GMP?