S4 Select Storage Solutions Scotland State of the art Storage facility offering all ICH and non ICH conditions as required.

Pharmaceuticals are required to be rigorously tested to ensure that quality, safety and efficacy are maintained. Of primary importance is how the drug will perform over its shelf life. This is known as stability, trials are set up and the drug is stored under set temperature and humidity. Photostability can also be determined.

It also acts as an aid to understand how drugs perform in warm and humid environments, for example South East Asia. Of importance is the manner in which samples are stored during stability studies. Samples must be held in appropriate conditions that do not contaminate the samples. Conditions must be constant. Samples can be expensive to produce, particularly those used in early phase development. Setting up a trial poorly can lead to the work having to be repeated; this may result in a loss of several years work.

The industry recognises the importance of competence and will only contemplate sub-contracting storage to the best companies. At S4 all of our Stability rooms/cabinets are fully validated upon installation. All rooms/cabinets are re-mapped and validated annually thereafter and of course if set points are changed. There is a housekeeping/maintenance rota for all rooms /cabinets. In the event of breakdowns we have a fully trained on site engineer and this is backed up by an on –call team We also have an external company on a 6 hour call out. We have an on site back up generator to cope with power outages.

This is a brief introduction on how we at S4 will manage your stability samples when placed on storage with us. Samples can come to us in many forms and can be stored for you at many different controlled conditions I will go over the life of a stability sample within S4.

The life cycle of a stability sample API Product Packaging Labelling Climatic Storage Testing Data Reporting Payment

The life cycle of a stability sample A.P.I A stability sample starts life as an A.P.I. This is an Active Pharmaceutical Ingredient ( Drug Substance)

The life cycle of a stability sample Product This is when the A.P.I is formulated into a medicine i.e tablet, capsule, MDI, DPI, injection, cream, lotion etc

The life cycle of a stability sample Client Notification The Client should inform the stability management staff and in some instances Q.A, of any proposed new studies at least 5 working days prior to set down date. Samples should be received no less than 3 working days prior to set down date.

The life cycle of a stability sample Assign STAB Number The SMP (Stability Management Personnel) will obtain the study number(s) from the stability index Each new product will have a unique identification number assigned. This unique number will be specific to the client involved and will not be used for any other client or product.

The life cycle of a stability sample PROTOCOL GENERATION This should be carried out by the SMP or trained delegate. This can be done using S4 protocol template

The life cycle of a stability sample PROTOCOL REVIEW AND APPROVAL Review should be carried out by trained SMP Q.A should also review/approve the protocol if it is a requirement of the contract Approval should be carried out by the client if requested.

The life cycle of a stability sample GENERATION OF STABILITY STUDY MASTER FILE On receipt of the approved protocols the stability management staff will generate a stability study master file. This SSMF will contain all documentation relevant to the particular client for their particular product.

The life cycle of a stability sample SAMPLE RECEIPT Once the Stability study protocol has been approved and signed the stability management staff can take receipt of the stability samples. All samples received will be stored at requested temperature prior to the set down date. The samples will be locked in a secure hold prior to set down date. Sample receipt will be documented on the relevant PF form.

The life cycle of a stability sample SAMPLE PACKAGING If the samples are not already in primary packs, the stability management staff will carry out this procedure All samples to be packed by S4 will follow a set procedure and all packaging details will be fully documented. All relevant documents will be placed in the SSMF.

The life cycle of a stability sample SAMPLE LABELING Preparation of labels and the labelling of samples is carried out by the stability management staff. All labelling activities are fully documented and PFs retained within the SSMF. STAB °C/60%RH Happy Pill Capsules 25mg HDPE Bottle with CRC Lot No: Timepoint:

The life cycle of a stability sample SAMPLE STORAGE PREPARATION It is the role of the stability management staff to ensure samples are set down in the correct storage conditions, including the correct requested orientation of samples, this will be detailed in the Stability Protocol.

The life cycle of a stability sample Stability Set Down The stability management staff will place the samples on storage as per the protocol on the day scheduled for set down. All documentation for set down will be retained in the SSMF.

The life cycle of a stability sample Sampling Timelines Unless otherwise instructed by the client the following sample/analysis timelines must be met. Timepoint Pull Window Test start window 0-13 wk+/- 1 day 7 days >13-52 wk+/- 3 days 14 days >52 wk+/- 7 days 14 days

The life cycle of a stability sample SAMPLE PULL Each week the stability management staff complete for the following week, a stability study pull schedule. This prompts for the sampling sheet to be filled out, indicating which day the samples are due and from which conditions. Once pulled samples will be dispatched to the client or contractor as requested via the protocol.

The life cycle of a stability sample All stability storage rooms/cabinets are linked to our IMS (Independent Monitoring System) The IMS gives us the capability to: Produce Graphs Review data Produce Client Reports for duration of study The IMS will send SMS and message out of hours to relevant SMP when an alarm excursion occurs. This is a fully validated system which is 21CFR part 11 compliant.

The life cycle of a stability sample Many Thanks for your attention and time Any Questions ?