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Checklist for QC Audit in Pharma Industry

Checklist for Laboratory in Pharma Industry Laboratories should be audited regularly and at least once per year. Auditing is an independent activity and separate from self-inspection. Auditing activities could include reviewing SOPs, worksheets, laboratory notebooks, balance calibration records, working control data, pipette calibration records, equipment monitoring logs and other related …

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Organization and Personnel in Pharma industry as per USFDA

Organization and Personnel in Pharma industry as per USFDA  Responsibilities of quality control unit (§ 211.22) in Pharma industry (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and …

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Contract production, analysis and other activities as per WHO Guideline in Pharma Industry

Contract production, analysis, and other activities in Pharma Industry Principle. Contract production, analysis and any other activity covered by GMP must be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a product, or work or analysis, of unsatisfactory quality. All arrangements for contract production …

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Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals

Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals A formal change control system should be established to evaluate all changes that may affect production and control of the intermediate or API. There should be a written procedure …

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Equipment Status log

Equipment Status log OBJECTIVE: To lay down a procedure of the maintenance of equipment sequential log. SCOPE: This SOP is applicable to all equipment and machines of all manufacturing departments RESPONSIBILITY: Production and Engineering officer/above shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY : Concerned Department Head and QA Head …

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QUALITY SYSTEMS MODEL (Resources)IN PHARMACEUTICAL INDUSTRY (Part – II)

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

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Pharma WhatsApp Groups for Latest Pharma Jobs, Pharma news and Pharma Post

Dear All Please find the Pharma WhatsApp Groups for Latest Pharma Jobs, Pharma news and Pharma Post. Please Click the below link and Join the group easily Pharma Vacancy https://chat.whatsapp.com/CjIJ1h6A0De05we3uX4hK0 Pharmaguidance 01 https://chat.whatsapp.com/EvhBElM2JcuBuOhn0YbPS6 Pharma Post and Jobs 01 https://chat.whatsapp.com/Dy1GkgHZloYJPsfzIC6tnZ Pharma Job & Post 02 https://chat.whatsapp.com/La8yGcVqeknKkfEeymYwMv Pharma jobs & post 03 …

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Pharmaguidances Whats App Groups

Pharmaguidances Whats App Groups Pharmaguidances   Pharma Post and Jabs     Pharma Vacancy Pharma Post and Jabs 2   Pharmaguideline   Pharmaguideline 2           MFR of SALBUTAMOL SULPHATE TABLET Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical …

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SOP for Operation, Calibration, and Cleaning of the Conductivity meter

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Operation, Calibration, and Cleaning of the Conductivity meter .2.0 SCOPE:This procedure shall apply to quality control of Pharmaceutical Company for Operation, Calibration, and Cleaning of the Conductivity meter .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in …

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SOP for Checklist for microbiology data Review.

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Checklist for microbiology data Review .2.0 SCOPE:This procedure shall apply to quality Control(Microbiology lab) of Pharmaceutical Company for microbiology data Review .3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention in this SOP. Concerned Department Heads shall be …

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