Compression Machine – Qualification (Operational) Compression Machine – Qualification (Operational) (OQ) involves identifying and inspecting equipment features that can impact final product quality Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by …
Read More »Compression Machine IQ (Installation Qualification)
Compression Machine IQ (Installation Qualification) Compression Machine IQ is a documented verification process that the instrument or piece of equipment has been properly delivered, installed, and configured according to standards set by the manufacturer or by an approved installation checklist. Installation qualification of Compression machine IQ requirements for equipment includes …
Read More »OQ of Blister Packing Machine (BQS)
OQ of Blister Packing Machine (BQS) TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Testing of Programmable Logic Controller’s Processor Verification of Man Machine Interface Screens – MMI Power & Emergency Failure Recovery Verification Emergency Operation Verification Verification of Alarms Operational Qualification Tests Status List of Standard Operating …
Read More »IQ of Blister Packing Machine (BQS)
IQ of Blister Packing Machine (BQS) TABLE OF CONTENT of IQ of Blister Packing Machine (BQS) Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Critical Instrument Calibration Verification Installation Qualification …
Read More »DQ of CONTA BLENDER
DQ of CONTA BLENDER TABLE OF CONTENT of DQ of CONTA BLENDER Objective Scope Responsibilities Machine description Operating control panel Main electric Panel Program of Bin Blender Program Data Program Spares Technical Specifications of Components & Sub-Components used/ bought outs Details of Utilities Identification of component for calibration Material of …
Read More »DQ for Purified Water System
DQ for Purified Water System NAME OF THE SYSTEM : PRETREATMENT & PURIFIED WATER GENERATION SYSTEM TABLE OF CONTENTS SR. NO. STAGE 1 OBJECTIVE & SCOPE 2 ACCEPTANCE CRITERIA 3 RESPONSIBILITY 4 SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM) 5 BASIS OF DESIGN AND ASSUMPTION 6 TECHNICAL SPECIFICATIONS 7 DRAWINGS REQUIRED 8 SUPPORTING …
Read More »USFDA Warning Letters 2016 (API)
Corden Pharma Latina S.p.A. 5/20/16 Megafine Pharma Limited 5/19/16 BBT Biotech Gmbh 5/16/16 Tai Heng Industry Co., Ltd. 5/12/16 Polydrug Laboratories Pvt. Ltd. 4/14/16 Apotheca Supply, Inc 4/7/16 Pharma More Jobs and post Please click here
Read More »DQ of Fluid Bed Processor
TABLE OF CONTENT OBJECTIVE SCOPE RESPONSIBILITIES MACHINE DESCRIPTION FLUID BED DRYER FLUID BED PROCESSOR LOADING & UNLOADING OF MATERIAL EQUIPMENT SUBASSEMBLIES & PARTS MAIN BODY AIR INLET SHUT OFF VALVE BLOWER INLET SHUT OFF VALVE AIR PREPARATION UNIT PRODUCT CONTAINER & TROLLEY DEHUMIDIFIER & MIST ELIMINATOR EXPLOSION FRAME & FLAP …
Read More »DQ of Blister Packing Machine (BQS)
DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) To design, engineer, and supply the Blister Packing Machine (Model: BQS) as per the URS and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there …
Read More »SOP on Requisition, Receiving and Counter Checking of Issued Raw Materials
Objective:To lay down a procedure for Requisition, Receiving and Counter Checking of issued Raw Materials. Scope :This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company. Responsibility: Trained Worker / Operator shall be responsible for performing the procedure as per this SOP. Production Supervisor / Officer shall be …
Read More »Review of Batch Manufacturing Record
Review of Batch Manufacturing Record Objective: To lay down a procedure for the review of batch manufacturing records. Scope: This Standard Operating Procedure is applicable for formulation plants of a Pharma company. Responsibility: Officer / Executive, Quality Assurance shall be responsible for reviewing Batch Manufacturing Record. Head – Quality Assurance …
Read More »In-process Controls in Tablet Compression and Capsule filling
In-process Controls in Tablet Compression and Capsule filling Objective: To lay down a procedure for conducting Inprocess Controls during Tablet Compression and Capsule Filling. Scope: This standard operating procedure is applicable to the formulation plant of a Pharmaceutical company. Responsibility: The production Executive / Officer shall be responsible for the …
Read More »Entry and Exit for Executives, Staff, Visitors in Production Area (gowning and degowning procedure).
Objective :To lay down a procedure for Entry and Exit for Executives, Staff, Visitors in Production Area (gowning and degowning procedure). Scope :This standard operating procedure is applicable for the entry and exit in Production Block of Pharmaceutical company. Responsibility: Executive / Staff / Visitors entering in production area shall …
Read More »Basic Requirement of Documentation and Records for GMP Compliance
Documentation and Records for GMP Compliance GOOD MANUFACTURING PRACTICES GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are …
Read More »Question and Answer on HVAC System
Question and Answer on HVAC Pharma More Jobs and post Please click here
Read More »COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION)
COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION) Table of Contents of compression machine URS General Salient Features Operational Requirements Utilities Maintenance Inspection and Testing Commissioning and Documentation Training Packaging Deviations Delivery TECHNICAL REQUIREMENT OF COMPRESSION MACHINE URS Equipment No. : To be embossed/imprinted conspicuously on the equipment Description: 37-station double rotary compression machine, …
Read More »Engineering Question & Answer
Engineering Question & Answer 1.Question:What is the good engineering practice (GEP) Answer: good engineering practice (GEP) means to established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions. 2.Question: How can defined the validation ? Answer: The documented act of proving that any procedure, process, equipment, material, …
Read More »SOP on New Product Design and Development Process
SOP on New Product Design and Development Process The objective of the New Product Design and Development Process : To lay down a Procedure for New Product Design and Development Process. Scope : This Standard Operating Procedure is applicable all pharmaceutical formulation plants of Pharmaceutical Companies. Responsibility Head, Clinical Research: …
Read More »SOP On In-process Control of Packing Line
SOP On In-process Control of Packing Line OBJECTIVE : To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY : In process Quality Assurance Officer / Executive shall …
Read More »SOP on Sampling of Intermediates and Finished Products
SOP on Sampling of Intermediates and Finished Products OBJECTIVE : To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE: This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY: In process Quality Assurance Executive/Officer shall be responsible for follow the …
Read More »