Doc

cGMP Checklist / Formats Doc QA Sop SOPs

Change Control Management Procedure (SOP)

Standard operating procedure (SOP) for change control management. Change Control Procedure is a formal controlled documented process by which qualified.

Read More
Blog cGMP Doc
  • December 18, 2023
  • by

Data Integrity: A Crucial Aspect of Pharmaceutical Quality

Data integrity is a fundamental pillar in the field of pharmaceuticals, playing a crucial role in maintaining the quality and.

Read More
Audit cGMP Doc Micro Sop QA Sop Quality Control SOPs
  • March 16, 2023
  • by

Product Dossier Registration Process

Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human.

Read More
cGMP Doc QA Sop SOPs
  • January 31, 2023
  • by

Good Clinical Practices (GCP) Guideline

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve.

Read More
Audit Calibration cGMP Checklist Checklist / Formats Doc Environment GLP Health & Safety (EHS) HPLC IT SOP Maintenance Sops Micro Sop Microbiology Production Production Sop Protocol QA Sop QC Sop Quality Control Research SOPs Sterile Stores Sops Validation
  • November 16, 2021
  • by

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.

Read More
cGMP Checklist Doc Micro Sop Microbiology Production Production Sop QA Sop QC Sop Quality Control SOPs Stores Sops
  • October 14, 2021
  • by

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.

Read More
Audit cGMP Checklist Checklist / Formats Doc GLP Health & Safety (EHS) IT SOP Maintenance Sops Micro Sop Microbiology Production Production Sop QA Sop QC Sop Quality Control SOPs Stores Sops
  • August 2, 2021
  • by

Regulatory Audit : Preparation & Handling

Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant..

Read More
Calibration cGMP Checklist Doc GLP Maintenance Sops Production Protocol QA Sop QC Sop Quality Control SOPs Stores Sops
  • January 9, 2021
  • by

User Requirement Specification (URS) Handling SOP

Standard Operating Procedure (SOP) for Handling of User Requirement Specification (URS) for a computerized system or Instrument / Equipment. User.

Read More
Audit Calibration cGMP Doc GLP Micro Sop QA Sop QC Sop Quality Control SOPs
  • October 24, 2020
  • by

Quality Assurance in Laboratory (Lab QA) – Guideline

Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA).

Read More
cGMP Doc GLP Maintenance Sops QA Sop Quality Control SOPs
  • October 21, 2020
  • by

Documentum Software – Guideline for Operation

Standard Operating Procedure (SOP) and Guideline for Operation of Documentum software for issuance, approval, rejections, and retrieval of forms and.

Read More
wpChatIcon
wpChatIcon
error: Content is protected !!