December 10, 2019

Complaints And Recalls Handling In API Manufacturing Unit- Pharma

Quality Assurance

COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure. Complaint records should include: − Name and address of complainant; − Name (and, where appropriate, title) and phone number of person submitting the complaint; − Complaint nature (including name and batch number […]

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Guideline for Buidlings & Facilities

Quality Assurance

BUILDINGS AND FACILITIES Design and Construction  Buildings and facilities used in the manufacture of intermediates and APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the

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