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1.0 OBJECTIVE
To provide guidelines and a framework for the preparation of technical terms of supply (TTS) between supplying and receiving organization (Company Name). A TTS document will provide a clear understanding of all technical and quality requirements, and agreement on the division of responsibilities by both Beximco Pharmaceuticals & the respective supplier.
2.0 SCOPE
This procedure shall be applicable for (Company Name) for preparation, management & control of Technical Terms of Supply document for agreeing with the supplier of various raw (active and the key excipients like Tetrafluoroethane HFA 134a, Ethanol, Microcrystalline Cellulose etc.) & primary packaging components.
3.0 RESPONSIBILITY
3.1 It is the responsibility of the Head of Quality or his nominee of the location to ensure that TTS agreement is done for procuring of materials from the respective supplier.
3.2 Head of Quality or his nominee is responsible for any change, if necessary, in the TTS agreement with the supplier through TTS change control form (Annexure – I).
3.3 Manager, QA or his nominee is responsible for revision, control & management of the SOP.
4.0 ACCOUNTABILITY
4.1 Executive Director, Quality
5.0 PRECAUTIONS
NA
6.0 PROCEDURE
6.1 Timing and need for Formal Agreements
Technical terms of supply (TTS) or equivalent formal agreement should be in place for each material (active, key excipients & primary packaging materials) received from the supplying organization.
6.2 Agreement by Both Organizations
Quality Assurance of Beximco Pharmaceuticals Limited (receiving organization) will generate the first draft TTS which will be finalized and formally agreed by both Head of Quality or designated person of supplying and receiving organizations.
6.3 Technical Contents in TTS
Quality Assurance of Beximco Pharmaceuticals Limited (receiving organization) will ensure that the following technical requirements are specified, either by inclusion in the TTS or by reference to other documents available to the supplying organization.
6.3.1 Quality Management
All material will be dispatched as passed stock.
6.3.1.1 BSE/TSE Statement
No materials of animal origin will be used within the process, unless controlled through Certificate of Suitability. If a Certificate of Suitability exists this will be provided to Beximco Pharmaceuticals Limited. BSE/TSE certificate will be provided to Beximco Pharmaceuticals Limited.
6.3.1.2 Product Quality Review
The materials produced by the supplier, are the subject of a Product Quality Review.
6.3.2 Materials Management
6.3.2.1 Batch Numbering
The batch number will uniquely identify the batch and will be of the format required by the manufacturing systems at the supplying site. For DMF grade material batch numbering system to be approved in the respective DMF.
6.3.2.2 Manufacturing date and Expiry date
Manufacturing date and Expiry date will be calculated and expressed as per company policy of the supplying site.
6.3.2.3 Shelf-life and storage condition
Shelf-life and storage condition of the material and retest date, if applicable, to be mentioned in the TTS agreement. For DMF grade material expiry and retest dating will be carried out in compliance with the approved DMF.
6.3.3 Production Operations
The materials will be produced using the approved manufacturing and control methods at the supplying factory.
No sub-contractors will be used for manufacturing and testing.
6.3.4 Packaging and Identification Labelling
6.3.4.1 Packaging Materials
This will provide adequate protection against deterioration or contamination of materials that may occur during transportation and recommended storage.
6.3.4.2 Packaging and Labelling Operations
Labels used on containers of materials will indicate the material name, identifying code, batch number, expiry/retest date and storage conditions as a minimum.
6.3.4.3 Anti Counterfeiting and Tamper Evidence
Anti counterfeiting and tamper evidence features will be in accordance with relevant SOP of the supplying organization.
6.3.5 Distribution
Following the principle of first in first out (FIFO), batches will typically be supplied in chronological order of date of manufacture.
6.3.6 Laboratory Controls
6.3.6.1 Testing
Testing of the material will be carried out at the supplying factory against approved specification and test method. For DMF grade material test must be done against the specifications agreed with the approved DMF.
6.3.6.2 A signed original copy of the Certificate of Analysis (CoA) from the supplier’s quality department will be despatched with the material. If a shipment is composed of many batches, the CoAs will be supplied in an envelope. In every case the original copy shall be sent by service mail or courier.
6.3.6.3The supplying organization will provided analytical work standard for actives and impurities to the receiving organization upon receiving request for such materials.
6.3.6.4 Retesting
Retesting of the material will be carried out as per approved method.
6.3.7 Change Control
Materials or specifications cannot be changed without prior written agreement of both parties. This will be managed through the change control process (Annexure – I).
All change control requests will be reviewed prior to implementation by the Quality department of the supplying factory. For DMF grade material, these changes will be approved in the DMF. Any changes to the final stage of manufacture that could or will affect the physical characteristics of the final product or will affect the chemical profile will be notified to the receiving factory’s Quality Assurance Department. For DMF grade material revised open part of DMF will be provided to Beximco Pharmaceuticals Limited.
6.3.8 Rejection of Materials
The disposition of any rejected or unwanted material will be carried out as per SOP at the receiving site (Beximco Pharmaceuticals Limited) with prior communication to supplying site.
6.3.9 Reprocessing and Reworking
The supplying factory will perform any reprocessing or rework in accordance with the relevant SOP. Receiving site (Beximco Pharmaceuticals Limited) will be informed of
supplying any reprocessed batch and the certificate of analysis will bear a suffix for reprocessed batch. For DMF grade material, for any reworked batch, the reworking process to be approved in the DMF.
6.3.10 Returns
Due to the complex operation of retuning goods from Bangladesh, any returns will be disposed of at the receiving site with prior communication to the supplying site.
6.3.11 Complaints
Any complaints arising should be referred to the supplying site for investigation. These should be directed to the Head of Quality of the respective supplying site.
The complaint responses will be addressed to the Head of Quality of receiving site (Beximco Pharmaceutical Limited) as appropriate. Response to complaints will be given as soon as possible, especially information about suitability of the material for use.
6.3.12 Recalls
In the event of a product recall the procedures followed will be in accordance with the relevant SOP of the supplying site.
6.4 Document Numbering
The unique document numbering for Technical Terms of Supply shall be done as per SOP for ‘Document Numbering System’ (QA003). QA of receiving site shall issue the
TTS document number and maintain the log register as per Form No.: FQA/091 (Annexure – II).
6.5 Retention
TTS agreement shall be retained in QA documentation area of receiving site.
