Quality Assurance

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 …

Guideline for Buidlings & Facilities Read More »

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 …

SOP on Cleaning Validation Read More »

Hazard and risk analysis in Pharmaceutical Products

Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. Hazard:-  Any circumstance in the production, control, and distribution of a pharmaceutical which can cause an adverse health effect. Hazard analysis:- The process of collecting and evaluating information on hazards which should be addressed in the HACCP plan. Traditionally, the Hazard Analysis and …

Hazard and risk analysis in Pharmaceutical Products Read More »

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 …

List of SOP for Pharmaceutical Quality Assurance Read More »

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 …

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

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

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 »

Training of employees

Training of employees PROCEDURE:                   Every employee of the organisation shall first undergo an Induction Training and then to be trained on his / her area of operation prior to start the work. Induction Training shall also include a visit and understanding of works done in Departments other than their own. An Induction Training Record …

Training of employees Read More »