SOP for Qualification of Quality Control analyst

Quality Control, SOP

   Objective To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification.     SCOPE:             This SOP is applicable for qualification of Quality Control analyst working in QC laboratory at manufacturing facility.     RESPONSIBILITY:             Manager – Quality Control and Head of Quality assurance is responsible for the qualification of Quality control analyst. […]

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Validation Master Plan

Quality Assurance

Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise and clear and contain at least the following: ‒title page and authorization (approval signatures and dates); ‒table of contents; ‒abbreviations and glossary; ‒validation policy; ‒philosophy, intention and approach to validation; ‒roles and responsibilities of relevant

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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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SOP on Cleaning Validation

Quality Assurance, SOP

OBJECTIVE  : The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting materials and products. SCOPE  : These SOP describe the general aspects of cleaning validation, Normally cleaning validation would be applicable for critical cleaning such as cleaning between manufacturing of one product and another, surfaces that

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Out Of Specification Investigation Phase II (MHRA)

Quality Control

Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not  reveal an assignable laboratory error.  Phase II investigations are driven by written and approved instructions against hypothesis.  Prior to further testing a manufacturing investigation should be started to determine whether there was a possible manufacturing root cause. If not already

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