APIC GMP Guidelines for Pharmaceuticals

Sathyanarayana M.Sc.
APIC GMP Guidelines for Pharmaceuticals

APIC GMP Guidelines for Pharmaceuticals:

APIC Means Active Pharmaceutical Ingredients Committee (APIC).


APIC's membership consists of companies from different pharmaceutical industry sectors, all involved in the manufacture of APIs. This provides an ideal basis for developing and communicating a balanced, holistic view on API-related regulations and guidelines.

APIC’s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to APIs and Intermediates. Through the years APIC has developed into a high-profile industry association with an excellent, worldwide reputation.

APIC has played and continues to play an important role in improving the regulatory environment for the API manufacturing industry, increasing patient safety and benefiting society as a whole. Some examples of its major achievements are:

➢ The development and adoption by the respective health authorities of a harmonised GMP standard for APIs (“ICH/Q7”) for the US, EU and Japanese markets.

➢ The issuance of a globally recognised APIC document on the interpretation of the ICH/Q7 guideline (“ICH Q7 How-to-do Document”).

➢ The initiation of the fight against unsafe, often low-priced rogue & counterfeit APIs. APIC is still playing a leading role in this fight together with the European Fine Chemicals Group (EFCG), another sector group of Cefic.

➢ The promotion of new attitudes within EU health authority circles which contributed to the currently running revision of the EU Variations Regulations.

APIC's Mission:

➢ To promote the use of compliant APIs in medicinal products to ensure patient safety.

➢ To represent the interests of European based companies producing APIs globally by being recognized experts who advance and influence the global GMP and Regulatory environment.

APIC's Major Strategic Objectives are:

➢ Networking/ Advocacy: to continually improve our contacts and to increase the profile of APIC with all relevant stakeholders.

➢ Level Playing Field: to strongly advocate regulatory compliance in all global markets and its enforcement through inspection.

➢ Post approval change authorisation: to put the responsibility to manage change into the hands of industry.

➢ Harmonisation: to support global harmonisation in the fields of quality and regulatory affairs.

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APIC GMP Guidelines for Pharmaceuticals:

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