OBJECTIVE To lay down a procedure for Calibration of Friability Test Apparatus to give accurate and reproducible data. SCOPE This Standard Operating Procedure (SOP) is applicable to In process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head–Quality Assurance PROCEDURE Operate the Friability test apparatus as per SOP No. …
Read More »Calibration procedure for disintegration test apparatus (ED-2AL)
OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus placed in IPQC lab and in Quality Control. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head–Quality Assurance PROCEDURE Check the water level in the water bath. …
Read More »Procedure for operation of weighing balance (Make: METTLER TOLEDO)
OBJECTIVE To lay down a procedure for Operation of weighing balance PB-303S. SCOPE This Standard Operating Procedure (SOP) shall be applicable for weighing balances installed in sampling booth. RESPONSIBILITYQuality Control Officer / Executive ACCOUNTABILITY Head – Quality Assurance\ PROCEDURE On/off switching Press < IB> key briefly. The balance performs a …
Read More »LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING LINE
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING LINE Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time PACKING [Released / …
Read More »BATCH MANUFACTURING RECORD (BMR)
BATCH MANUFACTURING RECORD (BMR) TABLE OF CONTENT GENERAL PROCESSING INSTRUCTION LIST OF EQUIPMENT USED DISPENSING OF RAW MATERIAL GRANULATION COMPRESSION COATING TABLET INSPECTION DOCUMENT RECONCILIATION BMR REVIEW BATCH RELEASE 1.0 GENERAL PROCESSING INSTRUCTION All the Activities shall be performed as per current SOPs. Follow GMP compliance throughout the manufacturing process. …
Read More »BATCH PACKING RECORD (BPR)
BATCH PACKING RECORD (BPR) BATCH PACKING RECORD (BPR) BMR Title : BPR for Tablet Document No. : Batch Size : Page No. : 1 of 15 Effective Date : Review Date : Product Name : Generic Name : Labels Claim) : Each _____________________________________ …
Read More »Procedure for operation of pH / CONDUCTIVITY METTLER (PICO)
OBJECTIVE To lay down the procedure for operation of pH / Conductivity meter (PICO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the pH / Conductivity meter (PICO). RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Control Manager. PROCEDURE PROCEDURE …
Read More »Operating procedure for milli Q water system
OBJECTIVE To lay down the procedure for Operation of Milli Q water system, Make Millipore. SCOPE This SOP shall provide the Operating procedure of Milli – Q water system of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE OPERATION OF ELIX –10 Switch on Elix …
Read More »Procedure for operation of SAS SUPER 100 AIR SAMPLER
OBJECTIVE To lay down a procedure for operation of SAS SUPER 100 Air sampler. SCOPE This SOP shall be applicable for viable air monitoring. RESPONSIBILITY Microbiologist ACCOUNTABILITY Head QC/QA PROCEDURE PRE START UP Remove the aspirating head. Insert an identified, closed contact plate and remove the lid of the plate. …
Read More »Humidity Chamber
Humidity chamber The purpose of humidity chambers is to test the influence of varying environments on products to determine the length of their usefulness and at what point they will fail. The collected data assists engineers in adjusting their designs and selecting more resilient materials. Humidity chambers play a crucial …
Read More »Operating procedure for ultrasonic bath
Operating procedure for ultrasonic bath. Quality assurance OBJECTIVE To lay down a procedure for operation and cleaning of ultra sonic bath SCOPE This SOP shall be applicable for operation and cleaning of Ultra sonic bath. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Head-Quality Control. PROCEDURE FOR CLEANING Switch OFF the equipment and …
Read More »Cleaning and operation of static pass box.
Objective :To lay down procedure for cleaning and operation of static pass box. SCOPE The standard operating procedure is applicable to the static pass box present in manufacturing plant . Equipment no. Make klenziad Capacity 915X610X915mm Location Under test area 3.0 RESPONSIBILTY Production executive/supervisor shall be responsible for implementing the …
Read More »Calibration procedure for gas chromatograph clarus 500 with head space (Perkin Elmer)
Calibration procedure for gas chromatograph clarus 500 with headspace (Perkin Elmer) OBJECTIVE To lay down the procedure for calibration of GC Clarus 500 with headspace (Perkin Elmer ) SCOPE This SOP shall be applicable for the GC Clarus 500 with headspace (Perkin Elmer). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality …
Read More »Area clearance during batch/product change over in Pilot Production facility. Quality Assurance
Area clearance during batch/product change over in Pilot Production facility. Quality Assurance OBJECTIVE : To provide procedure for Area clearance during batch/product change over in Pilot Production facility. RESPONSIBILITY : Officer Quality Assurance for implementation Quality Assurance Manager to ensure compliance. PROCEDURE : Note: (i) Type-A Area clearance : During …
Read More »Preparation, Approval and Control of Guidelines (Quality Assurance)
Preparation, Approval and Control of Guidelines (Quality Assurance) OBJECTIVE : To lay down the procedure for the preparation, approval and control of Guidelines. RESPONSIBILITY : All the personnel shall to be familiar with this SOP. The approver to ensure that all proposed Guidelines conform to this SOP before approving any …
Read More »Alu Alu Blister Pack Machine
Alu-Alu Blister Pack Machine Table of Contents General Salient Features Operational Requirements Utilities Maintenance Commissioning and Documentation Training Packaging Deviations Delivery TECHNICAL General/Equipment No./Description/Use Required Specifications Equipment No. It contains Ø Base film-loading station. Ø Pre-forming base film platen heating station.. Ø Cold forming station. Ø Feeding systems which are …
Read More »Technology transfer
Technology transfer OBJECTIVE : To lay down a procedure for technology transfer of New products . SCOPE : The scope of this SOP is to all the new Products for which Technology has been provided by outside party or from R&D. RESPONSIBILITY : Head of Production, QA Head, QC Head …
Read More »Correction of Documentation Errors
Correction of Documentation Errors Objective To lay down a procedure for correcting the errors in documentation. Scope This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.) Responsibility Each …
Read More »New Product Design and Development Process
New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable all pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data …
Read More »Approval of vendors (Packing Materials)
Approval of vendors (Packing Materials) OBJECTIVE: To lay down a procedure for approval of new vendors for packaging materials. SCOPE: This SOP is applicable to all new manufacturer / suppliers of packaging materials RESPONSIBILITY: Purchase, QC and QA personnel shall be responsible to follow the procedure mentioned in this SOP. …
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