We were listening when clients indicated a need for a GMP analytical laboratory that could provide integrity to a Quality Assurance program, but did more than just provide results. With the emphasis on value and service, see how far we’ve taken the concept.
First and foremost, our clients expressed a desire for a lab with exceptional communication, especially one that could provide advice and insight where needed. Secondly, clients wanted a lab that made them feel like it was their own, in short, they wanted a lab that was responsive to their needs, and always in their corner. With extensive experience in GMP manufacturing and compliance, Quality Control departments around the country now rely on Pia Pharma’s personalised, timely service and support to keep them on track, or be there to advise when things go awry. We have plenty of capacity in this area, and our GMP laboratory is extensively resourced in terms of electronic sample reporting, instrumentation, dissolution, physical and chemical testing for all product types. Talk to us about your analytical and support needs, we can tailor a package to suit.
As an extension to our GMP services, we’ve established sampling protocols, process validation protocols, and cleaning validation protocols for clients to implement in their manufacturing facilities as part of their continual improvement of manufacturing processes. Clients considering new facilities, introducing additional manufacturing equipment, or changing processes in a GMP environment should talk to us about their individual process validation requirements.
We have extensive, hands-on manufacturing and quality experience in all manufacturing categories, including sterile manufacture. We have practical experience and understanding of manufacturing equipment and processes, so we come up to speed very quickly when talking about your specific application. In addition to analytical services, clients have benefitted from our GMP experience in these areas.
- Manufacturing facility design – we workshop ideas, add insight, create concepts and designs that are practical, and facilitate efficient manufacturing processes and workflow,
- Critical systems design – HVAC, water/ steam production for sterile and non-sterile production processes,
- Facility qualification – preparation of documentation to support the commissioning of new manufacturing facilities,
- Equipment acquisition and qualification – documentation and execution of design qualification and equipment selection, Factory Acceptance Tests, Installation, Operation and Performance Qualifications,
- GMP documentation – Batch records, standard operating procedures, environmental monitoring, training records
- Validation Master Plans, Quality Assurance Manuals and associated working documents – we’ve applied the principles of GMP and created a network of documentation to capture the integrity of your manufacturing processes.
- Training – we offer practical, on-the-job training for staff involved in GMP related manufacturing services.
- Release for Supply – Pia Pharma is licenced by APVMA Manufacturers Licence Scheme to perform the Release for Supply step (Vet Chemical products only) – this could be a particularly useful should your QA delegates be unavailable.
If there is a GMP related service that you would like us to investigate, or establish, please contact us.
