SOP on Intermediate and finished product Analysis, Approval and Rejection

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

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

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

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

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

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

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

SOP on Chromatographic Practices and Documentation for Instrumental analysis

SOP on Chromatographic Practices and Documentation for Instrumental analysis Objective: To describe the procedure to be followed in Chromatographic Analysis and Documentation for instrumental analysis and to ensure that good laboratory practices are followed during instrumental analysis in the Quality Control laboratory. Scope: This procedure is applicable to Chromatographic analysis through HPLC & GC and … Read more

SOP ON INPROCESS CONTROLS

SOP ON INPROCESS CONTROLS PURPOSE: To lay down a procedure for in process control in dispensing area, oral preparation (Tablets, Capsules & Dry Syrup) and in Dry powder Injection. SCOPE: This SOP is applicable for the Tablet Capsule dry syrup orals dosage Forms and Dry powder Injections for different products manufactured RESPONSIBILITY: Preparation of SOP: Officer/ … Read more

SOP ON GAP ASSESSMENT

SOP ON GAP ASSESSMENT PURPOSE:  The purpose of this Standard Operating Procedure is to lay down the procedures for periodic review of respective standard operating procedures, Validation Procedure and other activities to find out the possibilities of improvement. SCOPE: This SOP is applicable for review and updating of standard operating procedure, Validation Procedure and other activities … Read more