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
SOP ON BATCH RELEASE SYSTEM OF FINISHED PRODUCT PURPOSE: To lay down a procedure for release of finished products for distribution. SCOPE: This SOP is applicable for release of finished product manufactured. 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 … Read more
ASSESSMENT OF CONTRACT ANALYTICAL LABORATORY FOR QUALIFICATION PURPOSE: To lay down the procedure for Assessment of Contract Analytical Laboratory for qualification. SCOPE: This Standard Operating Procedure is applicable for qualification of Contract Analytical Laboratory for analysis of samples for which in-house testing facility is not available. RESPONSIBILITY: Preparation of SOP: Officer/Sr. Officer QA Department Checking and … Read more
SELF INSPECTION CHECKLIST FOR WAREHOUSE RAW MATERIAL STORAGE AREA: General cleanliness Temperature and relative humidity measurement records Raw material receipt procedure Quantity verification of Raw material against purchase order Physical inspection of incoming goods for physical aspects Storage of materials as per the approved list of storage condition Weather freezer available for material stored at … Read more