PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM INDEX PART –I                                                                                                 Page no. Objective Brief Description Purpose Procedure Acceptance criteria PART –II Data generation for viable count PART –III Summary Recommendation Attachments PART-I  1.0          OBJECTIVE The objective of this study is to determine the efficacy of  UV germicidal lamp of Laminar … Read more

Unit Dose Sampling Procedure for Blend Uniformity

Unit Dose Sampling Procedure for Blend Uniformity OBJECTIVE To lay down the procedure for collecting unit dose blend samples for evaluation of blend uniformity so as to ensure accurate and consistent sampling. RESPONSIBILITY : Officer – Quality Assurance to collect the samples. Head of Quality Assurance to ensure compliance. PROCEDURE: Unit dose sampling procedure for … Read more

Worst case identification for cleaning validation

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 … Read more

Prospective Process Validation

Prospective Process Validation I. INTRODUCTION Validation is an essential procedure that demonstrates that a manufacturing process operating under defined standard conditions is capable of consistently producing a product that meets the established product specifications. Process validation is establishing documented evidence that provides a high degree of assurance that a specific process  will consistently produce a product meeting … Read more

VALIDATION MASTER PLAN

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 … Read more

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL S. No Table of Contents 1 General 2 Salient Features 3 Operational requirements 4 Utilities 5 Maintenance 6 Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery  TECHNICAL S. No. Parameters Requirement Specifications 1 1.1. General Equipment No’s.  1.2 Description 1.3 Use 1.4 Field Identification     To be … Read more

SOP for operation of Metal Detector for automatic capsule filling machine

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 … Read more

Installation Qualification for Pass Box

Installation Qualification for Pass Box TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 Equipment Identification 5.0 Equipment location 6.0 Documentation 7.0 Pre-requisite of Installation Qualification 8.0 Installation Qualification Procedure 9.0 System Description 10.0 Procedure 10.1 Installation Check List 10.2 Inspection Check list 10.3 Leveling and Alignment 10.4 Material of Construction Check Points 10.5 … Read more

Operational Qualification for Pass Box

Operational Qualification for Pass Box TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 5.0 Pre-requisite of Operational Qualification 6.0 Operational Qualification Procedure 6.1 Training 6.2 Instrument Calibration 6.3 Key Functionality 6.4 Test Data Sheet 6.5 Safety Features Test 6.6 SOP Verification 7.0 Deviation and Corrective action 8.0 Change Control Proposal 9.0 … Read more

MANAGEMENT REVIEW OF QUALITY METRICS

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, … Read more

Temperature Mapping

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, … Read more

Types of liquid column chromatography( HPLC)

Types of liquid column chromatography( HPLC) The type of liquid column chromatography (HPLC) can be classified on the nature of the stationary phase and the separation process. There Can be classified into three types Adsorption chromatography Ion-exchange chromatography Size exclusion chromatography Adsorption chromatography In adsorption chromatography the stationary phase is an adsorbent (like silica gel or … Read more

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

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 … Read more

SOP for environmental  monitoring of air

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 … Read more

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

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control procedure Qualification Document report approval Appendix … Read more

PERFORMANCE QUALIFICATION PROTOCOL

PERFORMANCE QUALIFICATION PROTOCOL TABLE OF CONTENTS 1.0       PROTOCOL APPROVAL 2.0       OBJECTIVE 3.0       SCOPE 4.0       RESPONSIBILITY 5.0       ACCOUNTABILITY 6.0       METHOD 7.0       RECORDING 8.0       ABBREVIATIONS 9.0       REFERENCES. 10.0     REVISION OF PROTOCOL   1.0     PROTOCOL APPROVAL: Protocol Prepared by: QA is responsible for the preparation of protocol for the Performance Qualification of the Nitrogen plant. NAME DESIGNATION SIGNATURE … Read more

Pass Box for Clean room and it validaton

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. … Read more

Reynolds number and its importance in water system

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 … Read more

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

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 … Read more

Procedure for calibration of balance XS 204 DR.

  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 … Read more