SOP on Precautions during on line maintenance of machine and re-start operation. Objective:To lay down a procedure for precautions during on line maintenance of machine and checks to start its operation. Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer / Executive …

Objective:To lay down a procedure for Checking of Strips / Blister and Overprinted Packing Materials. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer shall be responsible for implementation of this SOP. Head-Production / designee shall be responsible for compliance of this …

Objective:To lay down a procedure for precautions during power failure and checks to start the operation. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Operator / Production Supervisor / Officer shall be responsible for implementation of this SOP. Head-Production / designee shall be responsible …

 Objective:To lay down a procedure for cleaning and operating of Carton Sealing machine. Scope: This standard operating procedure is applicable for formulation plant of pharmaceuticcal company, Make and Model: Tapping System, Identification Number. Responsibility Production Operator shall be responsible for operating the machine as per the procedure mentioned in this SOP. …

SOP on Maintaining of Equipment Log Book Objective: To lay down a procedure for maintaining of equipment log book. Scope:T his Standard Operating Procedure is applicable for maintaining of equipment log book associated with product (s) manufactured at formulation plant. Responsibility All the concerned personnel shall be responsible to follow …

SOP On Issuance and Submission of Batch Manufacturing Record (BMR) Objective: To lay down the procedure for issuance and submission of batch manufacturing record (BMR). Scope: This SOP shall be applicable for issuance and submission of batch manufacturing record (BMR) to Production in Formulation plant.. Responsibility Production personnel shall be …

SOP on Recording of Specimen Signature Objective: To lay down the procedure to record the specimen signature. Scope: This Standard Operating Procedure is applicable for recording of specimen signature of all the personnel working at Pharmaceutical Company. Responsibility Concerned personnel of all department shall be responsible for following the procedure …

Preparation, Approval, Review and Control of MFC and MPC for Manufacture of Pharmaceutical Products Objective:  To lay down a procedure for the Preparation, Approval, Review and Control of MFC for Manufacture of Pharmaceutical Products. Scope:  This Standard Operating Procedure is applicable for preparation and implementation of MFR for all products …

CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER OBJECTIVE:  To lay down the procedure for calibration of Halogen moisture analyzer, Make-  Metler – Toledo. SCOPE:  This SOP shall provide the calibration procedure of Halogen moisture analyzer in in-process quality assurance  department and quality control department. RESPONSIBILITY : Officer/ Executive – Quality Control/Quality Assurance. …

Compression Machine OQ (Operational Qualification) TABLE OF CONTENTS FOR COMPRESSION MACHINE OQ Approval Objective Responsibility System Description Pre-requisite of Operational Qualification Operational Qualification Procedure Training of concern personnel Critical Instrument Calibration Key Functionality Test Test Data Report Sheet Safety key Features Test SOP Verification Deviation Details(If Required) Change Control (If …

Tablet Compression Machine IQ (Installation Qualification) TABLE OF CONTENTS Approval Objective Responsibility Equipment Identification Equipment location Documentation Pre-requisite of Installation Qualification Installation Qualification Procedure System Description Procedure Installation Check List Inspection Check list Leveling and Alignment  Material of Construction Check Points Certificates for motor Drawing Identification of Standard Operating Procedures …

Objective:To lay down a procedure for Transfer of Finished Products from Production to Finished Goods Store. Scope:This standard operating procedure is applicable for formulation plant. Responsibility Production Supervisor / Officer shall be responsible for checking the COA from QC, product name, batch number, date of manufacturing, date of expiry, quantity …

OBJECTIVE :To lay down a procedure for collection, storage, retrieval and disposition of Control samples of drug products. RESPONSIBILITY :Quality Assurance Officer for collection, storage, retrieval and disposal of Control samples. Head of  Quality Assurance Department to ensure compliance. PROCEDURE :Every batch/lot of each drug product in all forms of its …

Responsibilities of Quality Assurance Department OBJECTIVE: To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality  Assurance  department  shall   be  responsible to formulate systems for the implementation of cGMP …

In-process checks during Packaging Operation of tablets and capsules OBJECTIVE : To lay down the procedure for in-process checks during packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE: Inspection of Packaging Materials : Production …

RESPONSIBILITY :Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. OBJECTIVE :To lay down policy for calibration of Instruments/Equipment’s wherever applicable. Heads of the  concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products shall be calibrated. …

Numbering System for Qualification Documents, Protocols and Reports Objective  To lay down a procedure for assigning of number for qualification documents, protocols and reports. Scope  This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and …

Installation, Operational and Performance qualification of Equipment/Instrument. OBJECTIVE : To lay down the procedure for Installation, Operation and Performance qualification of Equipment/Instrument. RESPONSIBILITY : Validation team comprising of representatives from functional department,Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. …

Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material Objective:  To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Re-qualification of existing approved vendors. Scope: This Standard Operating Procedure is applicable for vendor qualification, De-qualification and Re- qualification …

Objective:To lay down a procedure for Calibration of equipments and instruments from external authorized Agencies / Supplier. Scope:This procedure shall be applicable for calibration of equipment / instrument of all the departments. Responsibility Head of Engineering: (i) For maintaining records (ii) For the selection of authorized calibration agency / Supplier …