Quality Assurance

Quality management system for Laboratory Management in Pharma

The laboratory or Quality organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes. The laboratory management should ensure that its policies, systems, programmes, procedures and instructions are described to the …

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Handling of Pharmaceutical Market Complaint

Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken. A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her. If this person …

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SOP For Job Responsibility

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Objective : The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Scope : This SOP is applicable to all responsible persons of pharmaceutical Industry …

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Validation Master Plan

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

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

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

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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List of SOP for Pharmaceutical Quality Assurance

SOP List for Pharmaceutical Quality Assurance. A list of Standard Operating Procedure for Pharmaceutical Quality Assurance Department required During Quality System Management Of Regulatory approved Manufacturing Sites. SOP of SOP SOP For Change control SOP For Handling of incidents and deviations SOP For Training of employees SOP For Self inspection SOP For Risk management SOP …

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Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals.

Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol. Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”). Operational qualification …

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