List Of Qa Documents In Pharmaceutical Industry -
In the pharmaceutical industry, Quality Assurance (QA) documentation follows a hierarchical "pyramid" structure designed to ensure every process is traceable, consistent, and compliant with Good Manufacturing Practice (GMP) standards. 1. High-Level Quality System Documents (Apex)
2. Document & Record Control
- Document Control Procedure – Defines how documents are created, reviewed, approved, distributed, and retired.
- Master Document Register (MDR) – A log of all controlled documents with version numbers.
- Record Retention Schedule – Lists types of records and their legally required retention periods.
- Template Library – Standard templates for SOPs, batch records, protocols, reports, etc.
Calibration Documents
- Expand any item into a detailed template (e.g., SOP template, validation protocol template), or
- Provide a prioritized roadmap for auditing/updating QA documents for a mid-size pharma site.
3. The Strategy: Master Formula Records (MFR)
Before a BMR can be created, there must be a Master Formula Record. This is the "recipe" for the product.
7. CAPA Documents
- CAPA Initiation Form – Triggered from deviations, audits, complaints.
- Root Cause Analysis Report – Using tools like 5 Whys, Fishbone, FMEA.
- CAPA Action Plan – Lists corrective/preventive actions with due dates.
- CAPA Effectiveness Check Report – Verifies actions prevented recurrence.
- CAPA Log – Master tracker for all CAPA records.
Stability Study Reports: Records proving the drug remains effective and safe throughout its shelf life. 4. Compliance and Safety Logs
In the pharmaceutical industry, Quality Assurance (QA) documentation follows a hierarchical "pyramid" structure designed to ensure every process is traceable, consistent, and compliant with Good Manufacturing Practice (GMP) standards. 1. High-Level Quality System Documents (Apex)
2. Document & Record Control
- Document Control Procedure – Defines how documents are created, reviewed, approved, distributed, and retired.
- Master Document Register (MDR) – A log of all controlled documents with version numbers.
- Record Retention Schedule – Lists types of records and their legally required retention periods.
- Template Library – Standard templates for SOPs, batch records, protocols, reports, etc.
Calibration Documents
- Expand any item into a detailed template (e.g., SOP template, validation protocol template), or
- Provide a prioritized roadmap for auditing/updating QA documents for a mid-size pharma site.
3. The Strategy: Master Formula Records (MFR)
Before a BMR can be created, there must be a Master Formula Record. This is the "recipe" for the product.
7. CAPA Documents
- CAPA Initiation Form – Triggered from deviations, audits, complaints.
- Root Cause Analysis Report – Using tools like 5 Whys, Fishbone, FMEA.
- CAPA Action Plan – Lists corrective/preventive actions with due dates.
- CAPA Effectiveness Check Report – Verifies actions prevented recurrence.
- CAPA Log – Master tracker for all CAPA records.
Stability Study Reports: Records proving the drug remains effective and safe throughout its shelf life. 4. Compliance and Safety Logs
