On November 1, 2023, the United States Pharmacopeia (USP) introduced significant updates to USP Chapter <797>, a set of guidelines that regulates the integrity of sterile compounding processes in order to prevent microbial contamination and ensure patient safety.
For ASHP’s list of key USP <797> changes, click here.
As a best-in-class partner, Pine Pharmaceuticals is committed to meeting the FDA’s stringent cGMP requirements to ensure we meet and exceed the standards outlined in USP <797>. Read more about Pine Pharmaceuticals’ response to USP <797> updates below.
Does Pine Pharmaceuticals comply with USP<797> for sterile compounding?
Yes. As an FDA-registered 503B outsourcing facility, Pine operates in accordance with current Good Manufacturing Practice (cGMP), thereby meeting and exceeding standards outlined in USP <797>.
Does Pine Pharmaceuticals establish expiration dates using the criteria outlined in USP <797> for Category 1, Category 2, and Category 3 compounded sterile preparations (CSPs)?
Yes. All products manufactured by Pine are subjected to stability testing both during development and on an annual basis. The results of stability testing are utilized to assign expiration dates to all compounded drug products.
Are personnel trained and qualified in accordance with USP <797>?
Yes. All personnel responsible for the compounding of sterile drug products undergo an extensive training program, including didactic learning, hands-on training, shadowing, gown and garb training and qualification, and media fill process validation. Aseptic operators complete annual cGMP training, semi-annual gown and garb assessments, and media fill assessments to demonstrate competency in sterile gowning procedures and aseptic manipulations.
Does Pine follow the steps outlined in USP <797> for personal hygiene and garbing
Yes. All personnel entering cleanroom areas perform hand washing and sanitization, followed by the donning of sterile garb components, covering all exposed skin from head to toe.
Does Pine Pharmaceuticals’ facility design, monitoring, and cleaning meet the requirements in USP <797>?
Pine operates out of a custom-built, state-of-the-art facility with aseptic manufacturing suites (i.e., cleanrooms) designed to ensure a sterile environment for compounded drug products. All cleanrooms are certified every six months and routinely monitored for the maintenance of pressure differentials, humidity, temperature, and environmental conditions, including airborne particulate counts and microbial air and surface sampling. All aseptic compounding areas are cleaned with sterile disinfectants, including sporicidal agents, per a routine schedule outlined in specific and detailed procedures.
What testing is performed on products before they are released
100% of batches manufactured by Pine are tested prior to release to ensure quality, including but not limited to, as appropriate:
- 100% visual inspection of all compounded units
- Potency of active ingredient(s)
- Sterility
- Endotoxin
- Sub-visible particulate matter
- pH
- Color & Clarity
Does Pine Pharmaceuticals have a formally established QA and QC program as outlined in USP <797>
The Pine Pharmaceuticals Quality Unit is responsible for the oversight of all Quality Assurance (QA) activities and Quality Control (QC) activities pertaining to raw materials, manufacturing, and finished drug products.
Quality Assurance consists of the members of the Quality Unit focused on oversight of manufacturing-related processes to provide proactive measures ensuring all quality requirements are fulfilled.
Quality Control is focused on fulfilling product-related quality requirements through manufacture, including raw material testing, in-process testing, and finished product testing.
All quality events, including out-of-specification results, complaints, and adverse drug events, are investigated thoroughly by the Pine Quality Unit.
Does Pine Pharmaceuticals comply with the storage, packaging, shipping, and transport criteria in USP <797>?
Yes. All products are packaged in accordance with Master Production Records, with container/closure systems, labeling, and outer packaging that have been assessed and qualified through the execution of stability studies. All finished goods are stored in a controlled and continuously monitored warehouse and shipped under controlled conditions by qualified logistics providers.