06 February 2019

2018 Audits

Our priority is to deliver the highest quality of products and services!

In 2018, we got 29 Customers’ audits which lasted 49 days.
At API Plant, we performed 4 GMP inspections. 3 inspections were run by Polish Main Pharmaceutical Inspectorate (GIF) and another one by US FDA (May 2018). The subject of those assessment varied depending on key objective of an audit.

API PLANT

The audits confirmed a correctness of our documents, like:  a list of qualified suppliers from which Polpharma purchases raw material, including packaging elements, equipment cleaning reports, batch production records. Moreover, the audit team presents procedures to confirm the manufacturing control, testing, quality, storage and distribution of our Active Pharmaceutical Ingredients (APIs).

In term of our infrastructure: building and facilities are the subject of the audit. Our utilities that can affect product quality (steam, compressed air, ventilation, etc.) were positively assessed. Additional audits verified water quality, adequate lighting, sewage, refuse and other waste.

As you can see, we are continuously passing many audits as the confirmation of Polpharma’s quality. Such great 2018 results are proof of our expertise and dedication at each stage of product life cycle.

For us, quality comes first.
With us, you'll get more.

Polpharma B2B Team

 

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