This category includes Quality Related SOP’s, i.e. Quality Assurance & Quality Control departments
Standard Operating Procedure (SOP) and format/Protocol of HPLC system calibration as per newly released Indian Pharmacopoeia (IP) recommendations. This Procedure is applicable for Shimadzu make HPLC and UPLC Systems, Agilent make HPLC Systems, Thermo make UHPLC & UPLC, Waters make HPLC Systems etc. HPLC Calibration Parameters are - Flow rate accuracy - HPLC Pump Calibration Temperature accuracy of HPLC column…
Calibration Policy/SOP - Instrument calibration is one of the primary processes used to maintain instrument accuracy. Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. Policy - Calibration of Instrument & Equipment 1.0 OBJECTIVE To define the policy for calibration of all master instruments and measuring devices used for measuring, monitoring…
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production. Media Fill Validation / Aseptic Process Simulation 1.0 OBJECTIVE To lay down the procedure to challenge the aseptic techniques used for sterile…
Safety work permit is a written record that authorizes specific work, at a specific location, for a specific time period. Permits are used for controlling and coordinating the work to establish and maintain safe working conditions. The permit is an agreement between the issuer and the receiver that documents the Conditions, preparations, precautions and the limitations that need to be…
Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of uses and calibration/qualification. Operation & Calibration Procedure for Top Loading Balance 1.0 Purpose : To lay down a procedure for Operation and Calibration of Top Loading Balance. 2.0 Scope : This SOP is applicable for Top Loading Balance used in…
Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of Data Integrity Incident 1.0 PURPOSE: To provide a procedure to investigate and handle data integrity incidences related to GXP data, identified during internal audit or during review of data. 2.0 SCOPE: Applicable to all GxP data generated by electronic and…
Standard Operating Procedure (SOP) and Protocol for Transport Validation through temperature mapping during transit of drug products. Transport Validation Procedure 1.0 Objective To lay down the procedure for conducting transport validation and to describe acceptance criteria for the study. The purpose of this SOP is to provide detailed steps to conduct transport validation and to evaluate the product integrity and…
Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose is to ensure that everyone uses the correct and current document processes and specifications. Documents and Data Control 1.0 Objective To lay down a procedure for control of documents and documented data. 2.0 Scope This SOP is applicable for the…
Reprocessing and reworking are considered non-routine events. Reprocessing: reprocessing is the introduction of an in-process material or drug product including one that does not conform to a standard or specification back into the process and repeating steps that are part of the approved manufacturing process / Primary packaging process. Continuation of a process step after a process test has shown…
Standard Operating Procedure for the handling of Tech Transfer documents received from transferring unit (TU)/ generated at receiving unit (RU) during tech transfer activity. Tech Transfer Documents 1.0 Objective To lay down the procedure for Handling Tech transfer documents for the products to be introduced/transferred at the site. 2.0 Scope This SOP is applicable to all Technology transfer (Tech Transfer)…
Standard Operating Procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. GC Column Management 1.0 Objective To lay down the procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. 2.0 Scope This SOP is applicable for all the GC columns used in Quality Control Laboratory 3.0 Procedure for GC Columns…
Standard Operating Procedure (SOP) for Reduce Testing in pharmaceutical starting materials (Raw Material) procured from approved vender. Reduce Testing Procedure 1.0 Objective To lay down a procedure for reduce the testing of raw materials. 2.0 Scope This SOP is applicable for Reduce Testing of raw materials procured from approved vender. 3.0 Procedure for Reduce Testing: Reduced Testing shall be done…
Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place. Equipment Qualification Procedure 1.0 Objective : To lay down the procedure for preparation of Qualification documents, execution of Qualification activities, Review and…
Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch documents and checkpoints. Finished Drug Product (Finished Goods) Release 1.0 Objective : To lay down the Procedure for release of Finished Products for sale & distribution. 2.0 Scope : This procedure is applicable to all products manufactured at pharmaceutical drug…
Standard Operating Procedure (SOP) for In - Process Quality Assurance (IPQA) check points and procedure during manufacturing of drug product in pharmaceuticals. In process Quality Assurance (IPQA) Checks 1.0 Objective : To lay down procedure for monitoring the In - Process Quality Assurance (IPQA) activities in stores and Production. 2.0 Scope : The SOP is applicable in stores and production…
Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of specification (OOS) test results. Laboratory Investigation Check Points / Report OOS Number : OOS login Date : Name of Product : Batch No. : Market : Batch Size / Qty : Mfg. Date : Test : G.R. No. / A.R.…
Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different stages like - In-process, Bulk, Intermediate, Finished Product & Stability Study Samples) Handling Out of Specification (OOS) Results 1.0 Objective : To lay down the procedure for investigation of Out of Specification (OOS) result(s) that occurs during sample testing in…
Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Checklist for Assessment or Evaluation of Vendor Vendor Assessment / Evaluation Questionnaire ( Manufacturer ) Name of the Material Questionnaire to…
Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the cGMP. Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Vendor Audit and Qualification Guideline 1.0 Objective : To lay down a procedure for…
Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to determine the self life of the drug product. Stability Chamber / Incubators Management 1.0 Objective : To lay down a procedure for Management of Walk in and stand-alone Stability Chamber. 2.0 Scope : This SOP is applicable for Management of…