Pharmaguidances

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

SOP on retesting of raw material Objective: To lay down the procedure for retesting 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. Accountability: Head – Quality Control. Procedure: Material shall be transferred … Read more

SOP On Entry, exit and gowning procedure in Quality Control Department Objective: To lay down a procedure for entry, exit and gowning procedure in quality control department. Scope: This SOP is applicable to entry, exit and gowning procedure in quality control department. Responsibility: Every person entering in QC department. Accountability: Head – Quality Control & Head – Quality Assurance Procedure: … Read more

SOP On General Laboratory Practices Objective: To lay down a procedure for General Laboratory Practices in the QC laboratory. Scope: This SOP describes the procedure for General Laboratory Practices in the QC laboratory. Responsibility: Chemist or above of Quality Control laboratory. Accountability: Head – Quality Control. Procedure: In Quality Control department, there shall be separate wings for wet lab, … Read more