Tag: Belarus

Worst case identification for cleaning validation

Posted on By Pharmaceutical Guidanace

Worst case identification for cleaning validation OBJECTIVE: Objective of this SOP is to provide the procedure to be followed during worst case identification for cleaning validation. It also includes updating of API solubility – potency matrix, calculation of acceptable residue levels during cleaning validation. SCOPE: This SOP covers the worst case selection criteria for validation…

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Quality Assurance

Prospective Process Validation of Paracetamol Tablets

Posted on By Pharmaceutical Guidanace

Paracetamol  Paracetamol/acetaminophen is the most commonly used analgesic and antipyretic drug, It is the drug of choice in patients who cannot be treated with non-steroidal anti-inflammatory drugs (NSAID), such as people with bronchial asthma, peptic ulcer disease, hemophilia, salicylate-sensitized people, children under 12 years of age, pregnant or breastfeeding women. It is recommended as a…

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Validation & Qualification

VALIDATION MASTER PLAN

Posted on By Pharmaceutical Guidanace

VALIDATION MASTER PLAN CONTENTS SR. NO. CONTENTS PAGE NO. 1 APPROVAL 2 INTRODUCTION 3 VALIDATION POLICY 4 OBJECTIVE 5 SCOPE 6 VALIDATION RESPONSIBILITIES 6.1 Validation Team Constitution 7 FACILITY DESCRIPTIONS AND DESIGN 7.1 General Description and Design Concept 7.2 Description of Products 7.3 Description of Process 7.4 Description of Equipments 8 VALIDATION PROGRAM AND SUPPORTING…

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Quality Assurance

USER REQUIREMENT SPECIFICATION (URS) OF PRESSURE VESSEL

Posted on By Pharmaceutical Guidanace

USER REQUIREMENT SPECIFICATION The User Requirements Specification (URS) outlines the business needs for what the equipment’s users need. URS are typically drafted early in the validation phase, often before the system is developed. URS is developed by the system owner and the end-users, with contributions from Quality Assurance. The requirements detailed in the URS are…

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Validation & Qualification

SOP for operation of Metal Detector for automatic capsule filling machine

Posted on By Pharmaceutical Guidanace

SOP for operation of Metal Detector for automatic capsule filling machine Objective: To lay down a procedure for operation of metal detector. Scope: This SOP is applicable for the operation of metal detector to the formulation plant of  PHARMACEUTICAL Company. Responsibility: Production Operator/ Technician – For operation of the machine. Production Officer/Executive-To ensure that operation…

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Production

Installation Qualification for Pass Box

Posted on By Pharmaceutical Guidanace

Pass Box A pass box is a component of a cleanroom setup designed to move materials from one side to another within a controlled setting to prevent contamination through the air. Its sole function is to transfer materials from one side to the other without causing any contamination issues, and it automatically removes any particles…

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Validation & Qualification

Operational Qualification for Pass Box

Posted on By Pharmaceutical Guidanace

Pass Box The static pass-through hatch is used wherever transfer of material is required in between the clean room and non-clean room or in between the clean room if different classifications. The product is provided with a door interlocking system and a minimum component of germicidal light may be fitted on an optional basis. The…

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Validation & Qualification

MANAGEMENT REVIEW OF QUALITY METRICS

Posted on By Pharmaceutical Guidanace

MANAGEMENT REVIEW OF QUALITY METRICS Management review of quality Metrics procedure provides Monthly/ Quarterly Management Review and assessment of the performance of Quality and GMP systems. This document describes the activities of the Quality review meeting. SCOPE OF MANAGEMENT REVIEW OF QUALITY METRICS: This procedure applies to all facilities related to Production, Packaging, Testing, Holding,…

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Quality Assurance

Temperature Mapping

Posted on By Pharmaceutical Guidanace

Temperature Mapping Temperature mapping involves systematically assessing temperature changes within a specific area. This area ranges from warehouses for storing temperature-sensitive pharmaceuticals to critical laboratory incubators needed for successful experiments. The goal is to detect potential areas of excessive heat or cold that may pose a risk to the quality and reliability of products, experiments,…

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Quality Assurance

Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

Posted on By Pharmaceutical Guidanace

Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance PAT FRAMEWORK PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. The term analytical…

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Audit and Guideline

SOP for environmental  monitoring of air

Posted on By Pharmaceutical Guidanace

SOP for environmental  monitoring of air OBJECTIVE  :To lay down a procedure for environmental  monitoring of air. SCOPE  :This SOP shall provide the procedure for monitoring the viable air borne count . RESPONSIBILITY :Microbiologist ACCOUNTABILITY Manager QC/QA PROCEDURE  The microbial environmental conditions  shall be monitored as per defined frequency and sampling schedule  by active air…

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Microbiology

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)

Posted on By Pharmaceutical Guidanace

Blister Packing Machine (BQS) The Blister Packing Machine consists of the following major stations Forming foil unwinding station This station is provided for various types of forming foils like PVC, PVDC, Alu-Alu, etc. The foil is clamped by the leading screw. The center distance concerning the base plate face is 170 mm, which can be…

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Validation & Qualification

PERFORMANCE QUALIFICATION PROTOCOL OF PURE NITROGEN

Posted on By Pharmaceutical Guidanace

 PURE NITROGEN PROTOCOL FOR PERFORMANCE QUALIFICATION Pure nitrogen is obtained by removing oxygen from the air in two stages. Oil-free compressed air is first dehumidified (anhydrous alumina is the desiccant) and is passed through a 0.01-micron filter and then a column of Carbon Molecular Sieve (CMS) where oxygen is adsorbed from this column. Then it…

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Validation & Qualification

Pass Box for Clean room and it validaton

Posted on By Pharmaceutical Guidanace

Pass Box for Clean room and it validation Definitions of Pass Box: Pass Box is specifically designed that aids in the material transfer without much personnel movement in clean rooms and also work like a barrier between classified and unclassified area.two types of pass box is used in pharmaceutical industry that is- 1.Static Pass Box 2….

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Audit and Guideline

Reynolds number and its importance in water system

Posted on By Pharmaceutical Guidanace

Reynolds number and its importance in water system Purified water is the most used ingredient in pharmaceutical industries its used directly for the drug manufacturing process and also used for equipment’s cleaning. Purified water and Purified water generation and distribution system is one of the most important and critical part of a pharmaceutical facility and during designing purified water generation…

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Audit and Guideline

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious).

Posted on By Pharma Editor

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious) Objective: To lay down a procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Scope The SOP describes the procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Responsibility Officers…

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Production

Procedure for calibration of balance XS 204 DR.

Posted on By Pharma Editor

  To lay down a procedure for calibration of Weighing Balance XS – 204 DR SCOPE This Standard Calibration Procedure (SOP) is applicable in quality control area. RESPONSIBILITY Quality Control Officer/ Executive ACCOUNTABILITY Head –Quality Assurance PROCEDURE PRE STARTUP Check the cleaning of the weighing balance especially pan & display terminal. Check the power supply…

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Quality Control

Factory Acceptance Test of Automatic Capsule Filling Machine

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Factory Acceptance Test of Automatic Capsule Filling Machine Table of Contents System Information Protocol Details Protocol Approval from Customer The objective of this protocol Scope of this Protocol Definition of FAT and SAT Acceptance Criteria Responsibility Customer Requirements Performance Check Points & Testing Machine Sr. number details AF T Lab Factory Acceptance Report Approval Final…

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Validation & Qualification