What is PIC/S: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities coming from all over the … Continue reading PIC/S Guidelines for GMP in Pharmaceuticals →

Air Sampler 1.          OBJECTIVE             1.1       To lay down a procedure for operation of air sampler. 2.         RESPONSIBILITY                                                                                       2.1       Microbiologist – Quality Control – To follow the SOP. 2.2       Manager – Quality Control – To ensure the compliance of SOP. 3.         PROCEDURE          3.1 Take the material required for sampling to the area for air sampling. 3.2 … Continue reading SOP for Operation of Air Sampler →

1.0       OBJECTIVE To lay down a procedure for operation of fume hood. 2.0       RESPONSIBILITY 2.1      Chemist / Executive - Quality Control - to follow the procedure. 2.2      Supervisor / Manager – Quality Control to ensure adherence to the procedure. 2.3      Head - Quality Control for implementation and compliance. 3.0 PROCEDURE 3.1      OPERATION Ensure that the equipment … Continue reading Operation of Fume Hood in Quality Control Laboratory →

1.0       OBJECTIVE       To lay down a procedure for the operation and calibration of High Pump for column washing Make:  Shimadzu. 2.0 RESPONSIBILITY 2.1       Chemist / Executive - Quality Control - to follow the procedure. 2.2        Head - Quality Control for implementation and compliance. 3.0 PROCEDURE 3.1 OPERATION Ensure that the working area is clean and … Continue reading Operation and Calibration of HPLC Pump for column washing →

What are nitrosamines? Nitrosamines, or more correctly N-nitrosoamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens (a substance capable of causing cancer in living tissue). Although they are also present in some foods and drinking water supplies, their presence in medicines is … Continue reading What is Nitrosamine Impurities →

1.         OBJECTIVE                           1.1      To lay down a procedure for handling of Expired Raw materials        2.         RESPONSIBILITY    Technical Assistant / Executive – Stores responsible to identify and segregate the  expired material QA - Executive shall be responsible to verify and labeling of the on-line rejected/expired material, to verify the non-conformance(s) if any and communicate to … Continue reading Procedure for handling of Expired Raw Materials →