Quality Assurance, GMP and Pharma Jobs

2011-01-17T10:25:00.000+05:30

Screening and Recruitment of Study Subjects in Clinical Research

2011-01-03T13:00:00.000+05:30

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Clinical Trial in Nut Shell

2011-01-03T12:58:00.002+05:30

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Operation and Calibration Of Ultraviolet Spectrophotometer

2010-12-24T14:42:00.001+05:30

Operation and Calibration Of Ultraviolet Spectrophotometer 4.0 PROCEDURE: 4.1 Procedure For General Cleaning: 4.1.1 Ensure that the

Procedure For Review And Approval Of Analytical Raw Data

2010-12-24T14:37:00.000+05:30

PROCEDURE 4.1. The reviewer shall ensure the following at the time of reviewal of the documents. 4.1.1. All the relevant details of the tested

Formats for sampling of Packaging material

2010-12-24T14:35:00.000+05:30

ANNEXURE - 1 REF. SOP NO.: Revision No. : 00 Page No.: 1 of 1 Effective From : PACKAGING MATERIAL REGISTER

Cleaning Of Laboratory Glassware

2010-12-24T14:24:00.000+05:30

Cleaning Of Laboratory Glassware 4.0 PROCEDURE 4.1 Cleaning of General Glassware 4.1.1 Dip the used glassware in a basin of water containing detergent. 4.1.2 Brush each item thoroughly, to remove stains and or grease. &

Sampling Of Packaging Materials

2010-12-24T14:22:00.000+05:30

Sampling Of Packaging Materials 1.0 RESPONSIBILITY 2.1 The Chemist / Assistant - Quality Control Packaging shall be:2.1.1. &

Sampling Of Sterile Raw Material

2010-12-24T14:19:00.000+05:30

4.0 PROCEDURE 4.1 Generate Sampler’s checklist-RM as per the Batch Number mentioned in the Under Test list and decide the number of containers to be sampled as per sampling plan (Annexure – I). 4.2 Check and reconcile number of containers and the total quantity as shown in

Raw Material (Rm) Sampling, Analysis And Approval (Non-Sterile)

2010-12-24T14:16:00.000+05:30

Raw Material (Rm) Sampling, Analysis And Approval (Non-Sterile) 1.0 OBJECTIVE The objective of this SOP is:1.1 To describe the procedure for sampling

Supporting Analytical Documents, Recording Result & Review Of Documents

2010-12-24T14:09:00.002+05:30

Supporting Analytical Documents, Recording Result & Review Of Documents 1.0 PROCEDURE 4.1 The review shall ensure for the following at the time of reviewing the documents. 4.2 Filling of all the relevant details in record of analysis (Green sheet) and certificate

Handling Of Sample For Analysis

2010-12-24T14:08:00.000+05:30

Handling Of Sample For Analysis 3.0 PROCEDURE 4.1 Raw materials 4.1.1 The Quality Control Officer shall receive the samples along with the GRN and ‘sampler’s &

Internal Audit check list for QC department

2010-12-24T14:05:00.002+05:30

Internal Audit check list for QC department Sr. No. Check points Observation (Yes/No) Comments Recommendation Action taken by 01 Is the control copy of QC department SOPs available? 02 Are the personnel having knowledge of current GMP requirements? 03 Is the

Internal Audit check list for Production department

2010-12-24T14:03:00.002+05:30

Internal Audit check list for Production department Sr. No. Check points Observation (Yes/No) Comments Recommendation Action taken by 1. Is the control copy of production department SOPs available? 2. &

Internal Audit Check list for Maintenance department

2010-12-24T14:02:00.000+05:30

Internal Audit Check list for Maintenance department Sr. No. Check points Observation (Yes/No) Comments

Internal audit check list for Store

2010-12-24T14:00:00.000+05:30

Sr. No. Check points Observation (Yes/No) Comments Recommendation Action taken by 01 Is the control copy of store department SOPs available? 02 Is the personnel having knowledge of current GMP requirements? 03 Is the incoming raw materials entry register available

Process Flow-Sheet of QA Person

2010-12-24T13:57:00.002+05:30

Process Flow-Sheet of QA Person Stage.1: BMR & R. M requisition issue by Quality Assurance (QA). Stage.2: Indent of R. M. & P.M. Requisitions by Production as per BMR. Stage.3: Requisition checking & stamping the BMR by Quality Assurance (QA). Stage.4: Dispensing of Raw & Packing Materials in presence of Production, QA &

Standard Operating Procedure : VALIDATION OF STEAM STERILIZATION

2010-12-21T14:48:00.000+05:30

Standard Operating Procedure : VALIDATION OF STEAM STERILIZATIONPurpose: • It is established for the proper validation of the sterilization process. 2. Scope: • It is applicable to microbiological Lab. 3. Responsibilities: • GM Production • Quality Control Manager • Microbiologist. 4. Procedure: • Biological indicators to be used: Strain of bacillus stearothermophillus ATCC 7953Ø • Take 3-4

Some Important Definitions

2010-12-20T10:49:00.000+05:30

self-contained areaPremises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings. specificationA list of detailed requirements with

Preparation Of Settle Plates

2010-12-17T15:28:00.000+05:30

1.0 OBJECTIVE: The objective of this SOP is:1.1 To lay down a procedure for preparation of plates that can be used as settling plates and in various

Operation And Cleaning Of Laminar Bench

2010-12-17T15:25:00.002+05:30

1.0 OBJECTIVE To lay down a procedure for operation and cleaning of Laminar bench. 2.0 RESPONSIBILTY Microbiologist/Executive. 3.0 ACCOUNTABILITY

Format: Environmental Monitoring In Microbiology Laboratory

2010-12-17T15:21:00.000+05:30

Annexure-IPERSONNEL / ENVIRONMENTAL MONITORING IN MICROBIOLOGY LAB.AS PER SOP DATE OF MONITORING EXPOSURE TIME ACTIVITY MONITORED BY PRODUCT BATCH NO. NO. OF PERSONS IN AREA OBSERVED ON PERSONNEL MONITORING BY CONTACT /PLATE METHOD IN MICRO. LAB. ( STERILE AREA ) NAME

Monitoring Of Personnel In Aseptic Area

2010-12-17T15:13:00.000+05:30

1.0 OBJECTIVE : The objective of this SOP is:1.1 To lay down a procedure for monitoring personnel of sterile area in aseptic area by taking finger and

Monitoring of aseptic area by passive air sampling (by settle plate method ).

2010-12-17T15:08:00.000+05:30

1.0 OBJECTIVE: The objective of this SOP is:1.1 To lay down a procedure for monitoring of aseptic area by passive air sampling ((Settle plate method

Monitoring By Active Air Sampler

2010-12-17T15:02:00.002+05:30

1.0 OBJECTIVE : The objective of this SOP is:1.1 To lay down a procedure for active air sampling in sterile area. 2.0