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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OBJECTIVE: The purpose of this SOP to lay down the procedure for Analytical Report (AR) numbering. SCOPE: This SOP is applicable for the procedure for Analytical Report (AR) numbering in Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible for follow the SOP. The Head of Quality
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SOP ON Receipt, Issue & Control Of Lab Chemicals OBJECTIVE: The purpose of this SOP is to lay down a procedure for issue, control and disposal of lab chemicals. SCOPE: This SOP is applicable for issue, control and disposal of lab chemicals in Quality Control Department at manufacturing site. RESPONSIBILITY: Analyst / Section Head or
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SOP On Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure for describe safety aspects and precautions during working in the department. SCOPE: This SOP on Safety in Quality Control Laboratory is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on safe
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SOP ON OPERATION AND CALIBRATION OF pH METER OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of PH Meter. Make:……, Model: ……. ID No: …… SCOPE: This SOP is applicable to PH Meter in the Quality Control Department at Pharmaceutical manufacturing facility. RESPONSIBILITY:
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SOP ON OPERATION AND CALIBRATION OF pH METER OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of PH Meter. Make: …… , Model: ……. ID No: …… SCOPE: This SOP is applicable to PH Meter in the Microbiology Department at Pharmaceutical manufacturing facility. RESPONSIBILITY:
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SOP For Preparation of Disinfectant Solution. OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to lay down a procedure for the preparation and usage of disinfectant solutions. SCOPE: This procedure is applicable to agents used for disinfection at the manufacturing facility RESPONSIBILITY: Officer/ Executive shall be responsible for the preparation and Head of
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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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SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). Scope:- The
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Good Documentation Practice in Pharmaceutical Industry ( As Per EudraLex Vol- 4) Principle Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System. Documentation may exist
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