VAL-155 Handling of Material Used for Trials

5.1 Overview

Trials take place in the manufacturing plant using non-standard raw materials or packaging materials; sometimes even pilot products or products from other sites in and out of Site can be involved in trials.  It is required that the movements of these materials in the plant is tracked and this procedure is to ensure that relevant documentation is created to accompany these materials in the plant.

5.2 Trials Using Raw Materials, Compounding Ingredients, Packaging Materials or Bulk Dosage Form for Core, Liquids and Packaging Areas.

As soon as it is known that the above materials are going to be arriving for a trial in the manufacturing area, a Manufacturing Instruction (MI) document or Packaging Instruction (PI) is to be raised using a Document Creation or Change Request form (Form-505).

The MI or PI should be marked with the letters “Packaging Trial” as part of the description of the job.

The following sections 5.2.1 to 5.2.7 apply to the MI and PI:

5.2.1 Lot Numbers and Identification

Must contain the producer’s lot numbers and the name of the source of the material or in house materials so that they can be identified. As much as possible of the supplied identification for the material is to be recorded to enable tracking of the details of the material. A batch number based on the format “8SBXX” where XX is a 2 digit sequential number is issued to the trial. This also separates the trial product from the batch numbers used for release for sale products.

5.2.2 Safety

Must contain the appropriate safety instructions; this can include MSDS information that could accompany the material.

5.2.3 Instructions

Must contain detailed instructions of how the material is to be handled and in what machinery and equipment it will be used.

5.2.4 Protocols

If a Process Qualification or Trial Protocol is involved with the work it is to be referenced

5.2.5 Cleaning

Procedures for recording machine cleanliness and readiness are to be followed, so there is a record of machine usage that can be related to the next product the machinery is used for.

5.2.6 Disposal

Once the trial is complete the disposal of the material should be recorded, for example “Moved to reject area of warehouse”.

5.2.7 Document Storage

Completed documents are to be stored with all other MI’s and PIs in the Quality Assurance Department filing system from where it can be retrieved if needed later.

5.2.8 Bulk/Placebo Trial Materials and Bulk Capsules

All bulk quantities of trial material must be stored in Quarantine Hold.

5.2.9 Notification of Planning / Commercial

Production and Commercial should be notified of the impending trial so that they can allow for its impact on production capacity.

5.2.10 Impact on Cleaning Validation Status

Any new excipients or API’s need to be evaluated for their impact on the cleaning validation status of equipment or process trains in the plant. Consultation with Technical Services or a specialist in cleaning validation will enable evaluation of the new materials against the Cleaning Validation Plan to determine if the new materials are a worst case for the equipment involved. A brief assessment report of this can be the documentation to show that this has been taken into account.

5.2.11 Non Standard Testing in QC Laboratory

Trial process will often result in samples to be tested by the QC Laboratory.  A QC Laboratory Analytical Testing Report for Non Standard Testing form (Form-715) must be provided to the Laboratory Manager. A copy of the relevant part of the protocol controlling the trial attached to the Non Standard Testing form (Form-715) will assist the Laboratory to know what is required.

5.3 General Items Applicable to Packaging and Manufacturing Trials Documents

Once the trial is complete, a reconciliation is to be calculated and recorded on the appropriate form with the MI or PI. When the trial is finished the materials are to be moved to the reject area and disposed of according to the appropriate SOP and guidelines.