Quality Assurance

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 […]

Complaints And Recalls Handling In API Manufacturing Unit- Pharma Read More »

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

Guideline for Buidlings & Facilities Read More »

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

SOP on Cleaning Validation Read More »

List of SOP for Pharmaceutical Quality Assurance

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

List of SOP for Pharmaceutical Quality Assurance Read More »

SOP For Corrective Action and Preventive Actions

Quality Assurance

SOP For Corrective Action and Preventive Actions   OBJECTIVE: Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP. SCOPE: This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility… RESPONSIBILITY: Officer

SOP For Corrective Action and Preventive Actions Read More »

Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals.

Quality Assurance

Performance Qualification In Pharmaceutical Industry. Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol. There should be documented records for the verification of performance (performance qualification report) to indicate the satisfactory performance over a period of time. Manufacturers should justify the

Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals. Read More »

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

Quality Assurance

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

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

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Quality Assurance

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.   Installation Qualification:- Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals   Read More »

Principles of Cleaning Validation

Quality Assurance

Principles of Cleaning Validation Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment. Simulating agents may be used with appropriate scientific justification. Where similar types of equipment are grouped together, a justification of the specific equipment selected for cleaning validation is expected. A visual

Principles of Cleaning Validation Read More »