Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on […]
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SOP ON BIO-BURDEN OF PACKING MATERIAL OBJECTIVE: The purpose of this SOP is to lay down the procedure for the bioburden of packing material. SCOPE: This SOP is applicable for bioburden of packing material at the Pharmaceutical manufacturing facility. RESPONSIBILITY: An authorized designee of the microbiology department shall be responsible for testing & documentation of
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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 On Cleaning Of Incubators OBJECTIVE: The purpose of this SOP is to lay down the procedure for Cleaning of Incubators. SCOPE: This SOP is applicable used in microbiology for Cleaning of Incubators laboratory at of Pharmaceutical manufacturing facility. RESPONSIBILITY: Microbiologist or his designee shall be responsible for Cleaning of Incubators. The Head of Microbiology
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SOP ON OPERATION AND CALIBRATION OF COLONY COUNTER OBJECTIVE: The purpose of this SOP is to lay down the procedure for Operation and Calibration of Colony Counter. SCOPE: This SOP is applicable for Operation and Calibration of Colony Counter ID No: —— used for the enumeration of microbial colonies on the agar plates in the
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SOP ON OPERATION AND CALIBRATION OF COLONY COUNTER OBJECTIVE: The purpose of this SOP is to lay down the procedure for Operation and Calibration of Colony Counter. SCOPE: This SOP is applicable for Operation and Calibration of Colony Counter ID No: —— used for the enumeration of microbial colonies on the agar plates in the
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SOP for Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure to describe safety rules and precautions during working in the Quality Control department. SCOPE: This SOP is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on the safe handling of various
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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
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What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological
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