Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0   Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]

Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0   Purpose :  The objective of this Guideline is to define the security controls for Computerized Systems that […]

Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0   Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]

Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0   PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit. 2.0   SCOPE This SOP shall be used as such […]

Standard Operating Procedure (SOP) for Local Area Network (IT Network / LAN) qualification procedure, Protocol, and related documentation. Procedure for qualification of IT network equipment’s for the fulfillment of availability of hardware as per requirement, guidance for re-qualification and to provide the procedure for numbering of network equipment. Qualification of Local Area Network (LAN) 1.0  […]

Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) Test Result in Microbiological Analysis. OOS results include all test results that fall outside of the specification or acceptance criteria established in drug applications, drug master files, official compendia, or by the manufacturer. Handling of (Microbiology) Out-of-Specification (OOS) Results 1.0   Purpose The objective of […]

Standard Operating Procedure & Guideline for preparation and control of Validation Master Plan (VMP) for Instrument, Equipment, Facility in the pharmaceutical drug manufacturing plant. SOP for Validation Master Plan (VMP) 1.0   PURPOSE The purpose of this SOP is to lay down the procedure of preparation and control of the Validation Master Plan (VMP). 2.0   SCOPE […]

Standard Operating Procedure for preparation and handling of different types of Technical Agreement. Agreement undertook by written and legally binding on two parties (Contract giver and contract acceptor). Technical Agreement 1.0   PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for the preparation and handling of all technical agreement (s). […]

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer System – IT Infrastructure Qualification 1.0   Objective  This Procedure defines the procedure for qualifying and maintaining the qualified status (Qualification) of Computerized Systems (CS) Infrastructure to ensure that Computerized Systems that use that infrastructure and […]

A placebo batch of a product is processed as per regular formulation of that product except for the active ingredient or A dosage form that is identical to the drug product except that the drug substance is absent or replaced by an inert ingredient or a mixture of the drug product excipients quantitatively equivalent to […]

Audit Checklist (s) for different department/section/area like – Engineering / maintenance, HVAC Area, Purified water system, Quality Control, Warehouse, Granulation, Compression, Coating, Packing / Packaging, Personal and administration (HR), Microbiology and Quality Assurance area etc. to check the effectiveness  of the implemented systems. Checklist for Routine Inspection /Audit 1.0   Audit checklist for Engineering area Sr. […]

Standard Operating Procedure (SOP) for Handling of Interim/On-line Rejection during manufacturing and packing of drug substances or drug product. Handling of Interim/On-line Rejection 1.0   Purpose : To define procedure for Handling of Interim/On-line Rejections during manufacturing and packing of drug substances. 2.0   Scope : This SOP is applicable for Handling of Interim/On-line Rejections during manufacturing […]

Standard Operating Procedure (SOP) for Gram’s Staining of Microorganisms. Gram stain or Gram staining, also called Gram’s method, is a method of staining used to distinguish and classify bacterial species into two large groups: gram-positive bacteria and gram-negative bacteria. The name comes from the Danish bacteriologist Hans Christian Gram, who developed the technique Procedure for […]

Standard Operating Procedure (SOP) for Handling, Investigation, Classification and Reporting of Incident by Environmental,  Health and Safety (EHS) department in pharmaceuticals. Incident Investigation, Classification and Reporting (EHS) 1.0   PURPOSE: To laydown a procedure to describe the incident, its classification, the requirement of investigation and its reporting procedure by Environment, Health and Safety Department (EHS). The […]

Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0   Objective : The objective of this protocol to provide the written guidelines for execution of the installation qualification of Programmable Logic Controller (PLC) based HMI System for ________ Define the installation qualification […]