Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

Author: Max Lazar
Under the Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, “manufacturing” is defined to contain all operations of receipt of materials, packaging, production, repackaging, labeling, quality control, storage and distribution of Active Pharmaceutical Ingredients (API) and the related controls. The Q7A guidance does not cover safety measures for environment or people involved in manufacturing. These controls are the sole responsibility of the manufacturer and are regulated by national laws.
Quality Management
All persons involved in manufacturing must be responsible for quality. Each manufacturer must establish and implement an effective system for quality management involving active participation of management and ideal manufacturing personnel. There must be separate quality units in the form of QA and QC, depending upon the structure and size of the organization. All activities related to quality must be recorded and any deviation from the regular procedure must be documented.
Quality Units’ Responsibilities
Quality unit(s) should review all quality-related documents. The important responsibilities should not be delegated. Key responsibilities include releasing or rejecting APIs, forming a system to reject or release raw materials, ensuring critical deviations are examined.
Responsibility for Production Activities
All the responsibilities for production activities must be expressed in writing, which includes preparing, approving, and circulating the instructions for the production of APIs as per the written procedures. The other key responsibilities include, reviewing every production batch records and making sure that these are finished and signed, ensuring clean production facilities, good maintenance of equipment and records.
Product Quality Review
All the responsibilities for production activities must be expressed in writing, which includes preparing, approving, and circulating the instructions for the production of APIs as per the written procedures. The other key responsibilities include, reviewing every production batch records and making sure that these are finished and signed, ensuring clean production facilities, good maintenance of equipment and records.
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