Whether purchasing a new process or equipment or updating existing documents the requirement to produce compliant and accurate documentation is essential. U Med Laboratories provides an excellent service in drafting of documentation for all areas within the pharma industry. We have assisted many clients over the years in drafting of design specifications and user requirement specifications for processes. Once the process has been procured we have written and performed factory acceptance tests in conjunction with the IQ, OQ and PQ documents for the equipment. Once the equipment had been installed and validated, U Med Laboratories can prepare all revalidation documentation, Batch manufacturing records & standard operating procedures.
U Med Laboratories can provide a stand-alone service where we project manage the drafting of all documentation for a particular process of for the entire plant. Alternatively U Med Laboratories can place an engineer into the existing project team where they can assist in the drafting of the documents.
Preparation of SOP's
The primary purpose of an SOP is to identify hazards associated with a specific operation and to document the means by which those hazards are mitigated.
Once a validated state has been achieved for a particular piece of equipment/system, U Med Laboratories have the expertise and experience to draft thorough and accurate operational procedures to ensure that the equipment is ran within its validated parameters and that the machine is maintained and remains operating correctly.
Examples:
Standard operating procedures for:
1. Revalidation procedures for all equipment/systems
2. Operating procedures for equipment/systems
3. Positioning of loads during autoclave processing
4. Procedures for writing documentation/Batch records
5. In house training procedures
6. Microbiology Laboratory sops
7. Production SOP
8. QMS System SOP
9. Aseptic processing SOP
10. VMP
11. Cleaning Validation Master plan
