Records Contract Manufacture

It benefits both parties of a contract manufacturing agreement to give specific details on the master production record when a pharmaceutical product will be manufactured by a contractor. Some items that need to be covered by an agreement include the following ... 

No changes to the batch record can be implemented without the written consent of both parties (contracting and contract manufacturing companies). 

Organizations are also responsible for ensuring that any contract manufacturers, suppliers, or third-party distributors used are made aware of the length of time they will be required to retain records of their activities either electronically or on paper, in case these may be required in the future. 

The personnel, premises, and equipment in the laboratories should be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations. The use of outside laboratories, in conformity with the principles detailed in Chapter 7 Contract Manufacture and Analysis can be accepted for particular reasons, but this should be stated in the QC records. 

Release for Sale should require the examination and certification by Quality Assurance of consolidated records of processing, packaging and quality control, to ensure compliance with the Master Formula, compliance with all procedures, acceptable yields and reconciliations and compliance with product specifications. A check list system should be used forthe collected documents to verify that all are present The release should include the dated signature of the person authorised to approve the distribution of the batch (see also Contract Manufacture). 

The responsibility of procurement then extends to include follow-up activities required to manage the performance and administration of orders and contracts - manufacturing surveillance and expediting, correspondence and records management, management of deUvery to site, payment management, disputes resolution, and order or contract close-out. 

The standard requires the supplier to investigate and confirm the manufacturing feasibility of proposed products in contract review and to record the results of the review. 

Poor Record Keeping. Unfortunately, many small industrial laboratories have inadequate records. This can have unpleasant consequences. In one case, the manufacturer of an alcohol solution was challenged by a customer about meeting specifications set forth in the contract. For his defense, he had not retained samples that could be traced to the disputed deliveries, and his only written information consisted of scribbled notes on loose sheets of paper from his desk drawer. He lost the contract. An independent investigation indicated that he had probably done his job right, but he had no way to prove it. 

The functions of an authorised representative are not precisely defined in the Directives except for the IVDD, but such a person is explicitly designated by the manufacturer, and acts and maybe addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter s obligations. It would be good practice for the manufacturer to have a written contract recording their relationship. 

A price calculation is relatively easy for a product with a track record of a regular industrial-scale production. On the other hand, it is difficult, if only a laboratory procedure exists and a calculation has to be made based on the virtual scaleup to industrial-scale production. The ability to perform this desk exercise in a quick and reliable fashion is an important competence criterion of a fine-chemical manufacturer. When setting a price, a separation of tasks must be made between the controller, who calculates the manufacturing cost, and the sales manager, who determines the sales price. If mistakes have been made and prices have to be changed, you will need facts to support your request. If a pivotal product is supplied, a supply contract is concluded. 

Maintenance has been by regular mechanics employed on the filter plant, or by mechanics and electricians employed in the pumping station division. Three exceptions have been a continuing contract for servicing of the refrigeration equipment by manufacturers representatives, the work of the mechanical engineer mentioned imder operation, and manufacturers servicing of the dew point recorder, which has been required on several occasions. 

Estimates of the number of people injured by pesticides vary widely but may be 100-times the accidental death rate on a worldwide basis (j5, 6). In 1985, 2500 occupationally-related accidental pesticide poisonings were officially reported in California and the real number of injuries may be considerably higher. Neither is the record of safety in pesticide manufacturing in the USA unblemished. Serious injuries to workers involved in manufacturing the insecticide chlordecone, the nematicide dibromochloropropane (DBCP), and, possibly, the insecticide leptophos have been reported in the last 15 years (4, ). There is preliminary but disquieting epidemiological evidence that frequent users of some herbicides may have an elevated risk of contracting cancer, particularly if standard safety precautions are not observed (e.g. 7.,8). 

Manufacturing, analytical, and distribution records and reference samples should be kept by, or be available to, the contract giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defed/recall procedures of the contract giver. 

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