PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM OBJECTIVE The objective of this study is to determine the efficacy of UV germicidal lamp of Laminar air flow and pass box with known microorganism. This ensure that the UV is effective enough to kill the microorganisms on exposure to defined period of time and … 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

PROCESS VALIDATION PROTOCOL OF PARACETAMOL 500 MG CAPLTES Batch size: 8,000,00Tablets (480.00 kg) ,Shelf life: 36 Months, Reason for validation: Introduction of New Product at Site (8.0Lac.) Table of Contents Pre- approval Objective Scope Responsibilities Reference documents Key equipment / instrument detail (qualification / calibration) Product detail Master formula Process description Process flow Risk assessment for critical … 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 Equipment No’s.  Description Use Field Identification:  To be installed in medicament preparation room in soft gelatin block. (i) Room Temperature NMT 25ºC and RH NMT 60 % (ii)  Non flame proof. Salient Features Material of Construction All the contact parts preferably should be of SS 316L. Finish: Internal / … 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 Approval Objective Responsibility Equipment Identification Equipment location Documentation Pre-requisite of Installation Qualification Installation Qualification Procedure System Description Procedure Installation Check List Inspection Check list Leveling and Alignment Material of Construction Check Points Guarantee / Warrantee Certificates Drawing Execution Identification of Standard Operating Procedures  Supporting Utilities Check Identification … Read more