Interpretation - quality management - chapter 1

As there is no Marketing Authorisation, as such, the product formulation must be in line with the order supplied.

If the order is not clear enough, then it should be clarified with the customer.

The product formulation is normally derived by appropriately qualified and experienced personnel, usually a qualified pharmacist.

The manufacturer should maintain a list of 'approved formulas' for each product type; these are normally translated to the formal batch record. In some cases, these formulas are held electronically.

For products supplied under Schedule 5A, Item 5 of the Therapeutic Goods Regulations 1990, the manufacturer is required to ensure that the product is not substantially similar to a product that is available commercially.

Orders can be received in any format (phone/fax/email), but normally in written form (including a prescription), with the order then used as part of the final release check. Any changes made to the order should follow and established process to ensure appropriate documentation and approval of any change to avoid any mix-up.

Manufacture in anticipation of an order:

Where products are manufactured under the provisions of Schedule 5A manufacture may proceed in anticipation of an order. However, all other conditions of Schedule 5A item 5 must be met.

Where products are manufactured under the provisions of Schedule 5, item 6, there needs to be an identified patient at the time of the compounding. Manufacture may proceed in anticipation of an order where the manufacturer holds evidence that the identified patient is undergoing a defined course of treatment.

The order (in written format) must be available at the time of performing the final check for product release. It can be an authorised photocopy of the original order.

The final product release must include an independent check against the original order. This is to include a physical check of the final product/s to be dispatched including any secondary labelling that is applied. This check must be recorded on the batch record. Any discrepancies should be investigated and appropriate corrective action taken before the product is released to the patient.

Where the batch is made in advance, the release should include verification that the QC testing results comply with the specification for those batches which are manufactured from API and excipients.

Product release is a real time activity; any subsequent review is a quality review tool and not a component of the release process for a given batch.

Trending and formal reviews should be performed for environmental monitoring results, complaints, and deviations.

Product Quality Reviews should be performed with the aim of assessing the suitability of existing operations, whether manufacturing processes are in control, and should address all relevant aspects of clause 1.4.

It is recognised that compounding encompasses a broad range of different formulations, strengths, and presentations in the products it produces and as such manufacturers may wish to group products or similar presentations for the purposes of generating a Product Quality Reviews. Any grouping applied to the products manufactured should be justified in accordance with risk management principles.

Risk management principles have been embodied in PIC/S PE009 as a means of assessing suitability of operations and justifying how requirements are to be met.

Risk management should be utilised to identify how GMP requirements are being met. It should not be used to justify how requirements set out in the PIC/S Guide to GMP can be reduced.