SOP on receipt and handling of stability samples Objective: To lay down a procedure for receipt and handling of stability samples. Scope: This SOP is applicable for receipt and handling of stability samples in Quality Control Laboratory. Responsibility: QC Chemist or above Accountability: Head – Quality Control Procedure: Receipt of stability samples : Samples for stability studies shall be … Read more
SOP on Pharmacopeial updation of documents as per the Pharmacopeial changes Objective: To lay down a procedure for Pharmacopeial updation of documents as per the Pharmacopeial changes. Scope: This procedure is applicable to Pharmacopeial updation of documents as per the Pharmacopeial changes.. Responsibility: QC Chemist or above & QA officer or above Accountability: Head Quality Control & Head Quality Assurance Procedure: … Read more
SOP on retesting of raw material Objective: To lay down the procedure for re-testing of raw material for material lying in warehouse for longer period. Scope: This SOP is applicable for retesting of raw material for material lying in warehouse for longer period. Responsibility: Chemist or above of QC Department & Officer or above of warehouse Department. Accountability: Head – … Read more
SOP on Sampling of Raw Material Objective: To lay down the procedure for sampling of raw material. Scope: This procedure is applicable for sampling of raw material Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from warehouse. Ensure that material is received from … Read more
SOP for Numbering system for analytical document to be used for regulatory submission Objective:- To lay down a procedure for numbering system for analytical document to be used for regulatory submission. Scope: This SOP is applicable for numbering system for analytical document to be used for regulatory submission in quality control laboratory. Responsibility: Chemist or above of QC … Read more
SOP for Maintaining Quality Control equipment / instrument log book Objective : To lay down the procedure for maintaining equipment / instrument log book in Quality Control Department. Scope: This procedure is applicable for maintaining equipment / instrument log book in Quality Control Department. Responsibility: Chemist or above of QC department Accountability: Head Quality Control Procedure: … Read more
SOP on Entry and Exit into Sampling Booth Area Objective: To lay down a procedure for entry and exit into sampling booth area. Scope: This procedure is applicable for entry and exit into sampling booth area. Responsibility: QC Chemist or above Accountability: Head – Quality Control Procedure: Entry Procedure into Sampling Booth Area: Enter into the personnel air lock … Read more
SOP on Intermediate and finished product Analysis, Approval and Rejection Objective: To lay down the procedure for analysis, approval and rejection of Intermediate and finished product. Scope: This procedure is applicable for analysis, approval and rejection of Intermediate sample, validation sample and finished product sample in QC Department. Responsibility: Chemist or above /Executive / nominee Accountability: Head – Quality … Read more
SOP on handling of alarm system of Stability Chambers Objective: To lay down a procedure for handling of alarm system of stability chambers. Scope: This SOP is applicable to handling of alarm system of stability chambers. Responsibility: Chemist or above of QC Laboratory. Electrician or above of Engineering department. Security supervisor or above. Accountability: Head – Quality … Read more
SOP on handling of rinse and swab sample Objective: To lay down the procedure for handling of rinse and swab sample. Scope: This procedure is applicable for handling of rinse and swab sample in QC Department. Responsibility: Chemist or above of QC department & Executive / nominee of QC department. Accountability: Head – Quality Control department. Procedure: In-process Quality Assurance personnel … Read more
