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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 …

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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. …

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Procedure for operation of walk in humidity chamber (25ºC/60%RH)

OBJECTIVE To lay down the procedure for operation of Walk in Stability Chamber (25°C/60%RH).   Model   : NEC-2530 RS Serial No.  : SCOPE This SOP shall be applicable for the operation of Walk in Stability Chamber (25°C/60%RH). RESPONSIBILITY QA Officer / Executive ACCOUNTABILITY Assistant Manager Quality Assurance PROCEDURE Operation of …

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Operating procedure for ultrasonic bath. Quality assurance

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 …

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Cleaning and operation of static pass box.

              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 …

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Calibration procedure for gas chromatograph clarus 500 with head space (Perkin Elmer)

Calibration procedure for gas chromatograph clarus 500 with head space (Perkin Elmer) OBJECTIVE To lay down the procedure for calibration of  GC  Clarus 500 with head space (Perkin Elmer ) SCOPE This SOP shall be applicable for the GC Clarus 500 with head space (Perkin Elmer). RESPONSIBILITY Quality Control Executive/Officer. …

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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 …

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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 …

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Alu Alu Blister Pack Machine

Alu Alu Blister Pack Machine Sr. No. Table of Contents 1 General 2 Salient Features 3 Operational Requirements 4 Utilities 5 Maintenance 6 Commissioning and Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery TECHNICAL  S. No. Parameters Required Specifications 1.        General  Equipment No. Description Use   Field Identification …

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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  …

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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 employee shall be …

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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 …

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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. ACCOUNTABILITY : QA Head …

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Vendor Development and Approval (API and excipients)

Vendor Development and Approval (API and excipients) OBJECTIVE : To lay down a procedure for vendor audit for raw material, developing and approving the vendor who can consistently supply the raw materials with right quality and quantity at right time. SCOPE : This Standard Operating Procedure is applicable to approve …

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Cleaning validation

Cleaning validation OBJECTIVE : Objective of this SOP is to provide the procedure to be followed during cleaning validation. SCOPE : This SOP covers the validation of cleaning procedure for equipment used for product manufacturing in pharm, company. RESPONSIBILITY : QA officer shall be responsible for issuing & implementation of …

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Process Validation Guidances: FDA and Global

Process Validation Guidances: FDA and Global   OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecycle Approach Stages 1 — Process Understanding (Process Design) 2 — Process Demonstration (Process Qualification) 3 — Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process …

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New EU Requirements for Qualification & Validation

  Updated version of Annex 15 ◦ Qualification and Validation Draft released in February 2014 Final version released on the 30th of March , 2015 Will be effective on 01 October 2015 4/3/2015 3 Improved Annex 15 May be used as supplementary optional guidance for active substances without introduction of …

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Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification

Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification Introduction  Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish …

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Good storage practices for pharmaceuticals as per regulatory Guideline

Good storage practices for pharmaceuticals as per regulatory Guideline 1. Introduction 2. Glossary 3. Personnel 4. Premises and facilities 5. Storage requirements 6. Returned goods 7. Dispatch and transport 8. Product recall 1. Introduction The storage, transportation and distribution of pharmaceuticals. The stability testing of pharmaceutical products containing well-established drug …

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The role of dissolution in drug development

The role of dissolution in drug development Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal …

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