The document pyramid: bringing order to a GMP site’s documentation
POMEX’s work at a pharmaceutical production site.
On a pharmaceutical site, every action must follow the right procedure and leave a record. That only works if everyone knows which document applies.
Our client had to bring order to documentation that had become hard to follow. POMEX built a clear document pyramid, from the quality policy down to the records.
01. Context and challenge
Over the years, documents had multiplied, department by department:
- scattered procedures, sometimes redundant, sometimes missing;
- different rules depending on departments and systems (ERP, CMMS, document management);
- strict traceability requirements: logbooks, post-intervention checks, sanitisation of purified water networks;
- responsibilities to be clarified between technical services, production and quality assurance.
02. Our approach
POMEX inventoried all the documents concerned and their status, then organised them into four levels:
- Policies and general procedures: the “what” and the “who”, for example how all maintenance activities are organised in the CMMS;
- Operational procedures: a clear flow for each type of activity (corrective, preventive, predictive, modification, adjustment, sanitisation…);
- Work instructions: the “how”, at the workstation;
- Forms and records: logbooks, checklists, checks when a component is replaced.
We started with technical services, where documentation was most fragmented, then applied the same logic to the interfaces with production and quality. Missing documents were written, duplicates removed and roles clearly assigned.
03. Results
The site now has clear and consistent documentation:
- everyone knows which document applies to their activity;
- fewer procedures, better linked together, and no more missing documents;
- consistent traceability between IT systems and the quality system;
- a solid basis for audits and inspections;
- a method that can be reused for any other department or site.
Conclusion
Well-structured documentation is not one more constraint: it is what allows teams to act quickly, correctly, and prove it.
