Master Formula Record (MFR) & Bill of Material (BOM) – Pharma
The Master Formula Record (MFR) and Bill of Material (BOM) are essential documents in the pharmaceutical industry, providing comprehensive details.
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Calibration
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HPLC
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Validation
- November 16, 2021
- by admin
Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain.
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- October 30, 2021
- by admin
Grounding Requirement for Equipment and Building
Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is.
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- October 14, 2021
- by admin
Reprocess Rework of API and Drug Product
Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product.
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Microbiology
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SOPs
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Validation
- September 8, 2021
- by admin
Media Fill Test – Aseptic Process Simulation in Micro
Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic.
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Doc
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- August 2, 2021
- by admin
Regulatory Audit : Preparation & Handling
Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant..
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Microbiology
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Validation
- May 28, 2021
- by admin
Validation Master Plan (VMP) Preparation Guideline
Standard Operating Procedure & Guideline for preparation and control of Validation Master Plan (VMP) for Instrument, Equipment, Facility in the.
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- May 5, 2021
- by admin
Technical Agreement – Preparation & Handling
Standard Operating Procedure for preparation and handling of different types of Technical Agreement. Agreement undertook by written and legally binding.
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- April 7, 2021
- by admin
Placebo Medicine Batch – Procedure for Handling
A placebo batch of a product is processed as per regular formulation of that product except for the active ingredient.
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Environment
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- March 17, 2021
- by admin
Audit Checklist – Department wise in Pharmaceuticals
Audit Checklist (s) for different department/section/area like – Engineering / maintenance, HVAC Area, Purified water system, Quality Control, Warehouse, Granulation,.
