VAL-165 Packaging Trials

1. Introduction

Trials are necessary for progress and can be of great benefit to the Company if properly designed, executed, fully evaluated and documented.

Because it is so easy to overlook secondary criteria beyond the immediate qualities being examined by the Trial, communication with the Management group and all stakeholders is essential to explore further potential and impact, which may be revealed by other tests within that Trial.

Additionally it is also beneficial to gain understanding and acceptance between Engineering, QA and Production.

2. Trial Stages

2.1. The Originator:

2.1.1. Must present the reason for the Trial and list the primary Trial objectives, (Attachment 2 lists examples of elements to be taken in consideration when planning Trials).

2.1.2. The originator must identify other stakeholders and assess the impact that the Trial will have on other departments, i.e. Production, Planning, Regulatory, QA and/or Validation.

2.1.3.  The originator must establish where the Trial is to be charged.

2.1.4.  The originator is to organise a Pre-Trial Meeting in order to collect or disseminate information and to establish Trial acceptance criteria, if applicable.

2.1.5.  The meeting to include: the area Production Manager, Production Planner, Technical Services, QA and Engineering representatives.

2.1.5.1.During this meeting the Trial is to be discussed and decisions made as to the need to manufacture one or more product batches and how large these batches need to be.  If the Trial involves manufacturing production batches, a decision needs to be made if they will be a saleable product.  In this case a separate Trial Protocol must be enclosed with the Final Packing documents and a QN needs to be raised.

2.1.6.  Trial Coordinator:

2.1.6.1.At the Pre Trial meeting a Trial coordinator is to be selected, who will be responsible for the following:

2.1.6.2.Filling in a Trial Preparation Summary (see Attachment 1.).  This document is sufficient to document simple Trials that don’t require production of a specific batch.

2.1.6.3.Ensuring a Trial protocol/report is written (see Section 4 for guidance) and approved by either Quality Assurance, Production Management or Technical Services Department as applicable.

2.1.6.4.Coordinating the Trial documentation, ensuring that at the end, a Trial conclusion is written and the Trial documentation is filed in the appropriate Technical Files or together with any subsequent Change Control.

2.2.  The Trial is executed in appropriate area and data/comments collected and conclusion formed.

2.3.  Complete Protocol sheet and submit to committee to authorise acceptance of change, if successful.  Use Change Control to introduce the change.
Note: If the Trial does not eventuate as scheduled, the documents must be returned to the Originator.

3. Trial Preparation Checklist (Considerations)

Attachment 1. Trial preparation summary and conclusion is to be used as an aid to summarise the Trial.  This document will only need to be signed off if it is to be used in lieu of a more extensive protocol, (i.e. type batch document),

Some of the following suggestion may or may not be applicable to the specific Trial, thus the Trial protocol or documentation needs to be flexible and suited for the Trial in question.

3.1.    New component:

Are all Trial components available?

Specifications and inspection plan available for Laboratory tests?

Note: Product should be tested before Trialled.  This implies a method should be available.

Does it fit the machine?  Organise a simple preliminary test, if applicable.

Can it withstand the usual treatment, e.g. autoclave?

Does it match or affect other components?

Does the Product Manager know about the change?

3.2.   Do not include too many variables in any one Trial, keep it simple; e.g. new product, new components and new machine should not all be tested at the one Trial.

3.3.  When products are packed for stability, ensure proper labels and cartons are specified and included in the Trial as these may influence stability.

3.4.  Clear instructions for each stage of filling, and packing to include process monitoring with stated limits.

3.5.  Sampling quantity to be meaningfully sized for full testing, and any specific procedures stated.
Trial batches will have special sampling needs.

3.6.  Leave adequate space on document (protocol) with each stage to encourage comments about problems, unusual events or results.

3.7.  Pilot batch Trials designed as near as possible to simulate production methods available, (mixing equipment type, solution filtration using positive pressure etc.).
Batch size is very important.

3.8.  The Production Manager is responsible for communication with Operators to discuss possible problem areas and report on performance afterwards (at Pre- and Post-Trial meetings).

3.9.    Evaluation of:

– Acceptance criteria/results.
– Machine performance or component.
– Stability where required.
– Whether the Trial product can be sold.
– Procedure for notification and actioning.

Follow up actions.

3.10.  How many batches are being evaluated?
Note: Any changes to equipment (validated or not) which have to be carried out specifically for a Trial MUST be documented and returned to standard following the Trial, unless required to become a permanent change in which case a Change Control needs to be raised to approve the change.

4. Protocol for Trials

4.1. This document is to include provisions for Batch Size, Batch Number, and protocol approval with Product name in heading.  It needs to clearly identify the Trial and significantly differ from normal hard copy product documents.

Attachment 1 can be used in lieu of a more extensive protocol if applicable.  In this case the document needs to be signed off by management.

4.2.  Use Key Words, on the Trial heading to help retrieval of document at a later stage or reproduction of it.

4.3. List the Trial Purpose and Trial objectives

4.4. Overall Conclusion/Evaluation is to be formed by the Trial Coordinator in agreement with the stakeholders.

4.5. Certification of Protocol/Trial Preparation Summary and Conclusion signed and dated by Quality Assurance Manager, Engineering or Production Manager (most applicable).

4.6.  The completed Trial file is listed with “Keyword/s” on the Technical File (Index) library, and the hard copy is kept in the Technical files.

5. Trial Completion

5.1. Draw up a follow up action plan if applicable.

5.2.  Raise a Change Control to introduce the Trialled and approved component or new method to production.

6. Attachment 1 – Trial Preparation Summary & Conclusion

Note: The following is an example of the points that should be considered when documenting a Trial.  It can be modified and adjusted according to Trial needs.

Request a Trial Protocol from Master Data when a full production batch is required for the Trial.

7. Attachment 2 – Required Physical & Chemical Testing & Observations of Trial Material

Appearance & Physical characteristics: