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
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 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 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
SOP FOR REPORTING OF INVESTIGATION PURPOSE: To lay down a procedure for reporting of investigation. SCOPE: This SOP is applicable to for the quality related failures of product, which do not meet the acceptance criteria. RESPONSIBILITY: Personnel of concern department are responsible for the Quality Related failures of product. Concern-HOD or designee shall investigate and … Read more
SOP ON BATCH CONVERSION PURPOSE: To lay down the procedure for Batch Conversion. SCOPE: This SOP is applicable for Batch Conversion Procedure. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer Checking and Review of the SOP: Executive/Sr. Executive Approval of SOP: Head of Department/ Assistant Manger Authorization of SOP: Head QA/Designee Head Production shall be responsible for initiating conversion … Read more
