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USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS
Read More »USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS
List of Documents required for Pharma Quality Control Departments (GMP & GLP Compliances)
List of Documents required for Quality Assurance Departments (GMP Compliances)
In-process control of oral drug product during manufacturing & Packing
Objective To lay down the procedure for in-process control of oral drug products during manufacturing & Packing. Scope This procedure is applicable for in-process sampling, analysis, and reporting to be carried out during manufacturing and packing of drug products at the formulation Plant. Responsibility Quality Assurance and production personnel shall …
Read More »SAMPLING OF PACKING MATERIALS
OBJECTIVE To lay down a procedure for sampling of packaging materials. SCOPE To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Assurance Manager PROCEDURE …
Read More »PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER
1.0 OBJECTIVE To lay down the procedure for operation and cleaning of unit dose sampler. 2.0 SCOPE This SOP shall be applicable for IPQA area in Quality Assurance. 3.0 RESPONSIBILITY In process Quality Assurance Executive /Officer 4.0 ACCOUNTABILITY Head Quality Assurance 5.0 PROCEDURE FOR OPERATING 5.1 Check the Status …
Read More »Batch Release Statement for Pharmaceutical Product
Procedure for Microbiological Monitoring of Purified water
SOP In-process Control of Packing Lines
SOP on Sampling of Intermediates and Finished Products
