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Dheeraj Pratap Singh is a professional pharmaceutical blogger from India having rich experience in the pharmaceutical field. He started his blog in 2019 with sharing his knowledge with Pharmaceuticals professionals. After getting a rich experience of Quality Control and Quality Assurance. In 2019, he started a question forum (ask.pharmaguideline.com) to provide a platform to the pharmaceuticals professionals to share their knowledge and views on different pharmaceutical topics. Now it has become a big community of about 500+ members. Where the community members solve the problems together. People love pharmaguideline because they found everything here that they want to know and learn. Writing on pharmaceuticals topics is his passion and it helps to improve his community. He is famous in the pharmaceuticals field and getting a hung number of daily readers. He shares his knowledge and career of pharmaceuticals professionals in pharmaceutical industries.

Dheeraj Pratap Singh is a professional pharmaceutical blogger from India having rich experience in the pharmaceutical field. He started his blog in 2019 with sharing his knowledge with Pharmaceuticals professionals. After getting a rich experience of Quality Control and Quality Assurance. In 2019, he started a question forum (ask.pharmaguideline.com) to provide a platform to the pharmaceuticals professionals to share their knowledge and views on different pharmaceutical topics. Now it has become a big community of about 500+ members. Where the community members solve the problems together. People love pharmaguideline because they found everything here that they want to know and learn. Writing on pharmaceuticals topics is his passion and it helps to improve his community. He is famous in the pharmaceuticals field and getting a hung number of daily readers. He shares his knowledge and career of pharmaceuticals professionals in pharmaceutical industries.

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Checklist for Audit in Sterile Area

Checklist for Audit in Sterile Area Checklist to verify the sterile manufacturing area before the audit. 1. Is there any SOP giving details for activity/ movement in the sterile area. 2. Verify the suitability of system for sanitization of hands. 3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available? 4. Verify the availability of following records: Air pressure differential Particulate monitoring Temperature Humidity Microbiological monitoring by settle plate 5. Are these records available and maintained as per SOPs? 6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs. 7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person? 8. Are the location for settle plates identified and the chart/ layout available with plant? 9. Are the following areas monitored for parameters mentioned in step 4: Air-lock to the critical ar...

MSDS (Material Safety Data Sheet)

MSDS What Is an MSDS? An MSDS (Material Safety Data Sheet) is a document that provides detailed information about a chemical substance, including its hazards, safe handling procedures, storage requirements, and emergency measures. Today, MSDS is more commonly called SDS (Safety Data Sheet) under the Globally Harmonized System (GHS). Why MSDS / SDS Is Important Protect workers and employees Ensure safe handling and storage of chemicals Prevent accidents and injuries Provide emergency response information Comply with workplace safety regulations. MSDS (Material Safety Data Sheet) International safety standards. GHS – Globally Harmonized System Full form: Globally Harmonized System of Classification and Labelling of Chemicals Develop by United Nations (UN). OSHA (USA) – Hazard Communication Standard (HCS) Factories Act & Chemical Rules (India) Factories Act, 1948 Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 REACH (Europe) REACH Regula...

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture sterile pharmaceutical products as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the FFS and BFS is to reduce the contamination by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...

Sterility Testing by Direct Inoculation Method

Sterility Testing by Direct Inoculation Method Direct Inoculation Method Learn the procedure for sterility test for sterile pharmaceutical products by direct inoculation method. 1.0 Objective : To lay down Standard Operating Procedure is to provide guidelines for sterility testing by Direct Inoculation Method. 2.0 Scope This procedure is applicable for the products manufactured at the location which can not be tested by Membrane Filtration Method. 3.0 Responsibility Implementation: Microbiologist 4.0 Accountability Execution: Manager - QC Review & Approval : AGM - QA / QC Procedure Direct Inoculation Method Sample for Finished Products: Collect the samples to be tested for sterility. Out of the whole sample, randomly select 20 articles of each lot of batch for both LVP and SVP t erminal ly sterilized products and for aseptically filled products. Sample for Intermediates: Randomly collect 16 pre-sterilized bottle samples to be tested for sterility from LVP bot...

Pharmaceutical Guidelines

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