This category includes Production Related SOP’s i.e. Manufacturing & Packing
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…
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 (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 & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove residue of the previous product below established acceptance limit. The acceptance limit is maximum allowable quantity of product residue, which does not affect quality and safety of the subsequent product to be manufactured, by using same equipment and facility. Cleaning…
Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of drug products. Failure Investigation 1.0 Objective : To lay down the procedure for failure investigation of any activity to meet its predetermined specification, limits or acceptance criteria. 2.0 Scope : This SOP is applicable to process failure as well as…
Guideline and Formats for Microbiological Environmental Monitoring (EM) of various area like in Production, Microbiology laboratory, Dispensing & Sampling Area, and Manufacturing Area etc. Microbiological Environmental Monitoring (EM) 1.0 Objective : To lay down a procedure for microbiological of environmental monitoring. 2.0 Scope : This SOP is applicable for microbiological environmental monitoring of area in Production, Microbiology laboratory, Dispensing &…
The Microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare or cosmetics manufacturing samples that range from raw materials to finished products. Microbial limit test (MLT) 1.0 Objective : To lay down a procedure for microbial limit test (MLT). 2.0 Scope : This SOP is applicable in…
Standard Operating Procedure for Cleaning and Operation of Vibro Sifter. Pharmaceutical Vibro Sifter is used to separate mass composition of solids, liquid from solid and grading the material as per particles size. It is a type of pharmaceutical machine used for separation of pharmaceutical solids or liquids. Vibro Sifter - Operation & Cleaning 1.0 Objective To lay down the procedure for cleaning & operation of…
Standard Operating Procedure for Operation and Cleaning of Tablet Compression Machine, the basic principle behind the compression machine is the hydraulic pressure. Tablet Compression Machine 1.0 Objective : To lay down the procedure for cleaning and operation of Tablet Compression Machine (35 Station). 2.0 Scope : This SOP is applicable in Manufacturing Area Tablet at pharmaceutical drug manufacturing plant. 3.0 …
