SOP FOR ANNUAL PRODUCT QUALITY REVIEW PURPOSE: To lay down the procedure for preparation, review and approval of annual product quality review (APQR). SCOPE: This SOP is applicable is applicable to APQRs for products manufactured. RESPONSIBILITY: Preparation of SOPs: Officer QA Department Checking and Review of the SOPs: Officer QA Department Approval of the SOPs: … Read more
SOP FOR PROCEDURE FOR ASEPTIC PROCESS SIMULATION (MEDIA FILL) PURPOSE: To define the procedure to be followed for validation of aseptic processes by process simulation study through a media fill. Process simulation study provides a way- To demonstrate the capability of the aseptic process in producing the sterile drug product. To qualify the personnel involved … Read more
SOP FOR INVESTIGATION OF MEDIA FILL FAILURE PURPOSE: To lay down a procedure for Media fill failure Investigation. SCOPE: This Standard Operating Procedure is applicable for Media fill failure Investigation. RESPONSIBILITY: Preparation of SOP: Officer QA Department Checking and Review of the SOP: Executive QA Department Approval of SOP: Executive QA Department Authorization of SOP: Head … 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
SOP on Backup / restore and archive of analytical data in electronic form Objective: To describe the procedure for backup / restore and archive of analytical data in electronic form. Scope: This SOP is applicable for backup / restore and archive of analytical data in electronic form in quality control laboratory. Responsibility: QC Executive or Nominee & QA Officer … Read more
