Deviation Handling and Quality Risk Management This guidance Based on WHO recommended requirements, these documents provide further explanations with examples in order to facilitate implementation. Deviation handling Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. The potential deviations are identified and …
Read More »Procedure for Operation & Cleaning of Mass Mixer
Procedure for Operation & Cleaning of Mass Mixer 1.0 OBJECTIVE: To Lay Down the Procedure for Operation & Cleaning of Mass Mixer. 2.0 SCOPE: This SOP is applicable for production Department for Operation & Cleaning of Mass Mixer 3.0 RESPONSIBILITY: 3.1 Officer production & …
Read More »Operation & Cleaning of Laser Printing Machine
Operation & Cleaning of Laser Printing Machine 1.0 OBJECTIVE: To Lay Down the Procedure for Operation & Cleaning of Laser Printing Machine. 2.0 SCOPE: This SOP is applicable for production Department for Operation & Cleaning of Laser Printing Machine 3.0 RESPONSIBILITY: 3.1 Officer production …
Read More »Operation & Cleaning of Induction Sealing Machine
Operation & Cleaning of Induction Sealing Machine 1 OBJECTIVE: To Lay Down the Procedure for Operation & Cleaning of Induction Sealing Machine. 2.0 SCOPE: This SOP is applicable for production Department for Operation & Cleaning of Induction Sealing Machine 3.0 RESPONSIBILITY: 3.1 Officer production …
Read More »Checklist in Quality control for Audit Preparation of FDA & USFDA
Checklist in Quality control for Audit Preparation of FDA & USFDA Personnel Organogram of Quality control departments List of Employee and education details Individual Job Description Training Record of Individual employee as per individual Job Responsibility and Training Log and training assessments records Analyst Qualification records as per individual Job Responsibility and …
Read More »LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER
LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER Dosage Form: Date / Time: Product: Batch No. : Previous Product: Batch No. : Vacuum cleaner ID No.: Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time Vacuum cleaner Equipment ID No.: …
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 »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 »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. …
Read More »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 …
Read More »CLEANING VALIDATION FOR DRUG PRODUCTS
CLEANING VALIDATION FOR DRUG PRODUCTS To establish and explain the procedure to be followed for the Validation of Standard Cleaning Procedures (SOP’s), in order to demonstrate that cleaning procedures are effective, adequate and shall consistently remove the residues (chemical, microbial and cleaning agent, if any) from the equipment to a …
Read More »Process Validation Guidance: FDA and Global
Process Validation Guidance: 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 of …
Read More »New EU Requirements for Qualification & Validation
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 …
Read More »Concept of URS,DQ,IQ,OQ,PQ in Pharma
Concept of URS,DQ,IQ,OQ,PQ in Pharma 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 documented evidence …
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