Media received and preparation Management 1.0 OBJECTIVE Lay down the procedure for Media received and preparation Management 2.0 SCOPE This procedure is applicable for Lab media management at …… 3.0 RESPONSIBILITY • Department microbiologist, officer and executive shall be responsible to follow the procedure of preparation and usage of sterile media as per … Read more
Investigation and Root cause analysis 1.0 OBJECTIVE: To lay down the procedure for Investigation and Root cause analysis. 2.0 SCOPE: This procedure is applicable to abc company. facility for investigation and root cause analysis of un explained discrepancies resulting from below listed area but not limited to. 2.1 People 2.2 Process 2.3 Material … Read more
Operation and cleaning of Automatic Four Head ROPP Cap Sealing Machine 1.0 OBJECTIVE : 1.1 To lay down a procedure for Operation and cleaning of Automatic Four Head R.O.P.P. Cap Sealing Machine. 2.0. SCOPE : 2.1 This procedure is applicable to Operation and cleaning of Automatic Four Head R.O. P. P. Cap Sealing … Read more
Sop for Cleaning Validation and Hold Time or Shelf Life Study Protocols and Reports OBJECTIVE: To lay down a Procedure for Preparation of Cleaning Validation and Hold Time/Shelf Life Study Protocols and Reports. 2.0 SCOPE: This SOP is applicable for Preparation of Cleaning Validation and Hold Time/Shelf Life Study Protocols and Reports in Quality Control … Read more
sop for outsourcing 1.0 OBJECTIVE: 1.1 To lay down a Procedure for outsourcing. 2.0 SCOPE: 2.1 This Standard Operation Procedure is applicable to outsourcing 3.0 RESPONSIBILITY: 3.1 Officer / Executive- QA shall be responsible for monitoring this SOP. 3.2 All department head responsible for implementation of this SOP. 3.3 Head – QA or his designee … Read more
procedure for cleaning validation 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for cleaning validation 2.0. RESPONSIBILITY: 2.1 The Officer – Quality Assurance shall be: 2.1.1. Responsible for carry out the sampling as per sampling plan mentioned in protocol. 2.1.2. Responsible for sending intimation to Quality control for … Read more
sop for Media Fill Study 1.0 OBJECTIVE: 1.1 To lay down a procedure for Media Fill Study. 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for the Aseptic process simulation with documentary evidence in Liquid injection block 3.0 RESPONSIBILITY: 3.1 Quality Assurance To organize the Activity. To prepare the Protocol and Report. To … Read more
List of Instruments Quality Control Department Quality control instrument is used in chemical, instrumental and microbiological testing pharmaceuticals and other sector Example Apathic, Ayurveda Unani drugs as per given standards. The list of instruments used in Quality Control department. 1) HPLC ( High Performance Liquid Chromatography) 2) FTIR ( Fourier transform infrared) 3) … Read more
Procedure for Microbiologist and QC Chemist Qualification OBJECTIVE : 1.1 To describe the procedure for qualification of analyst. The purpose of this exercise is to ensure that the analyst is qualified for Microbial Limit Test and Sterility and Bacterial Endotoxin Test prior performing the tests on regular basis. 1.2 … Read more
ANALYTICAL METHOD VALIDATION PROTOCOL FOR BENZYL ALCOHOL BY HPLC Name of Product BENZYL ALCOHOL Parameter Analytical Method Validation for Benzyl Alcohol by HPLC Method followed By HPLC Supersede No. Nil Total No of pages Effective Date Sr. No. Title Page — Product Description — Table of contents 1.0 … Read more