Preston Pharmaceuticals (PP), Royal Preston Hospital (Lancashire Teaching Hospitals NHS Foundation Trust) and The customer
SCOPE
This statement defines the roles and responsibilities between The Customer and PP relating to the manufacture and delivery of the products supplied under MS21327.
SUBJECT OF THE AGREEMENT
PP is subject to registration and inspection by the MHRA and holds the necessary manufacturing licence according to the respective legislation, MS21327.
PP hereby acknowledges that The Customer is relying on the skill and experience of PP in the proper manufacture and delivery of the contractual products under this Agreement and PP accordingly warrants to The Customer that:
• The product shall be made in compliance with Good Manufacturing Practice.
• The product shall comply in all respects with orders placed by The Customer.
PP is responsible for ensuring that manufacture and distribution of products meets all current legislation and best practice guidelines.
The customer confirms they will not further supply any products purchased from PP under a WDA (H) licence.
SPECIAL CLINICAL NEED
All orders must be placed in conjunction with guidance note 14. All new product requests must detail is there a special need for this product as defined in Human Medicines Regulations 2012 Regulation 167.
PP will only produce unlicensed medicines where there is no licensed medicine with an equivalent presentation available.
PRODUCT SPECIFICATIONS
PP will provide a product specification for all manufactured products ordered by The Customer. This will be required to be accepted by The Customer prior to acceptance of any order.
PP will provide a sample of the label for all pre-packs and over-labels for The customer approval prior to acceptance of any order. The customer will be informed of labelling changes of significance e.g., change to BNF warnings.
NEW PRODUCT REQUESTS
All new product requests are considered, in accordance with GN14.
All requests must be supported by a new product request form (PPFORM 36, available from prestonpharmaceuticals@lthtr.nhs.uk). Upon receipt of the form, a quotation will be provided. Once an order is placed, the new product will be placed into the system for process. A lead time of 4 weeks, following agreement is requested for all new product requests.
ORDERS
The Customer shall submit an official order, stating the PP product code, for all products purchased. Orders should be placed by email: prestonpharmaceuticals@lthtr.nhs.uk
Cancellation of orders may be possible, on discussion with the Customer Services team, should the order not be in manufacture and any costs been incurred by PP.
For any items made to order, a storage facility may be available, however would be subject to storage charges and will only be available on full payment of the invoice.
Call off orders are available and can be discussed.
Orders under the value of £100 will be subject to a £25 administration charge. For non-stocked lines there will be a minimum order quantity of 100 packs.
A notice period of 3 months is required for ceasing use of a product; this is to reduce wastage both financially and environmentally.
PRICING
All prices are quoted on request. All prices will be reviewed on an annual basis and changes notified in advance of 1st April each year.
PP reserves the right to adjust prices throughout the year without notification due to the fluctuation in raw material pricing.
PAYMENTS
All payments must be made in accordance with the terms and conditions stated on each invoice received.
DELIVERIES
Deliveries will be made by the approved contractor, Polar Speed, between the hours of 08:00 and 18:00 Monday – Friday.
Any discrepancies or damages must be reported to PP within 72 hours of order receipt.
PARTY RESPONSIBILITIES
1. Regulatory Processes
PP shall provide adequate premises, equipment and staff to satisfactorily carry out the work undertaken. PP shall perform all operations in accordance with Good Manufacturing Practice.
PP shall ensure pharmacovigilance systems are in place to collect and collate information concerning all suspected adverse events / reactions reported to The Customer.
PP shall ensure competent authorities are notified of all complaints concerning suspected adverse events / reactions / lack of effect according to existing regulations and requirements.
PP shall ensure that all products are prepared in compliance with GMP.
The customer is responsible for ensuring the product is suitable for the intended clinical use.
The customer is responsible for ensuring the product has a specific clinical need where there is a licensed medicine available.
The customer is responsible for reporting pharmacovigilance events to PP.
2. Starting / Raw Materials and Excipients
PP purchase Active Pharmaceutical Ingredients are from bona fide suppliers of pharmacopoeia quality and have been assessed and approved for compliance with SI 2003/1680 for the absence of BSE/TSE contamination.
PP are responsible for procurement of any licensed raw material for re-packing/over-labelling will be purchased where possible via CMU.
3. Packaging Material
PP only purchase primary packaging materials from approved suppliers in accordance with a specification.
4. Processing
PP ensure that all products are manufactured in accordance with the agreed specification, current legislation, according to applicable GMP requirements for production equipment, facilities and processes.
Ensure all labelling of products is in compliance with all laws, regulations and guidelines associated with the labelling of unlicensed specials.
5. Stability
PP ensure stability data supports the allocated expiry of the products. Methods to determine product stability shall be in line with current regulatory requirements.
6. Product release
PP will release products following approved procedures, to include confirming the batch complies with all release criteria as detailed on an approved product specification. PP ensure the released product conforms to order placed by The Customer.
PP provide certificate of analysis for manufactured products. PP provide certificate of conformity for liquid dose pack-downs.
7. Storage / Distribution
PP will store all products and/or starting materials / other ingredients / excipients / auxiliary materials under appropriate conditions in compliance with GMP/GDP requirements and any licence requirements. PP shall store, handle and be responsible for the distribution of the product according to its defined storage conditions.
PP shall ensure all products are packaged in such a way as to give them adequate protection from damage during transit.
PP shall ensure that products will be delivered in accordance with agreed procedures and records of delivery and receipt shall be retained by each party to affect a satisfactory audit trail in the event of recall.
8. Change Control
PP will maintain a suitable change control system.
PP will ensure results of any investigation relating to a major or critical unplanned deviation for a product made under this agreement shall be provided in written format to The Customer within 72 hours of completion and prior to release of the product. This investigation must include proposed corrective and preventive actions.
9. Complaints
PP will acknowledge any complaints from The Customer with quality implications within 24 working hours. PP will investigate and document any complaint relating to the quality of contracted products within 10 days, feedback may be in the form of an interim or final report. This document will include details of all corrective and preventive actions as appropriate.
10. Recalls
PP will ensure that in the event of a product, starting material or component being recalled either by PP or subject to MHRA Drug Alert or Recall, will advise The Customer and arrange for the collection and segregation of products affected. This also includes products which were manufactured using a recalled starting material or component. This will comply with timelines as specified in regulations.
PP will maintain a product recall procedure for use when it is necessary to recall a defective product from market and test the procedure at least annually.
AGREEMENT
Any orders placed to Preston Pharmaceuticals following receipt of this service level statement will be taken as agreement to the terms and conditions as stated.
