Manufacturing records

In cases of unclear manufacturing records (documents, etc.), a confirmation test using western blotting (for egg or milk) or PCR (for wheat, buckwheat or peanut) should be performed. 

Manufacturing records I Manufacturing records I Manufacturing records H Manufacturing records... 

Additional supporting documents are also included in the manufacturing records. These may include computerized print-outs from weighing equipment used to dispense chemical raw materials, or recorder charts obtained, e.g. from a freeze-drier upon completion of freeze-drying that batch of product. 

The manufacturing records identifying the inspections and test status are maintained with a specific batch number. 

Refs l)Anon, Barrage Balloon Manufacturing , Manufacturers Record 112,36-7(1943) 2)E ncycl Britannica 2,(1952), 1011 3)Collier s Encycl(1957) 12,380(under Lighter-than-Air Craft )... 

Ensure that manufacturing records for CTM production are maintained and available for audit. 

Pharmaceutical and healthcare companies must then, in turn, themselves validate all the computer systems used to fulfill operations governed by GxP regulations. Software and hardware must comply with GxP requirements for manufacturing records and equipment, respectively. 

Remember that the GxP requirements for computer data are the same as for manufacturing records and documentation. Similarly, computer hardware (operating platforms and supporting networks) should fulfill the GxP requirements of manufacturing equipment. 

Batch documentation is an important factor. Preparation of master batch records in accordance with plant standard operating procedures (SOPs) should be followed by an approval of the document by the sponsoring division, usually the formulator or process development staff of the R D unit. On completion of a batch, review of the batch records by the quality assurance group ensures compliance to GMP and that all necessary deviations from and modifications to the manufacturing records are properly explained and documented. 

Out-of-limit results (e.g. action limit deviations) should be recorded and form part of the batch manufacturing records. 

Manufacturing procedure Outline of manufacturing and packaging Copy of the master formula and a copy of a manufacturing record Details of sterilization Stages of sampling and in-process control tests ... 

Batch manufacturing records (verification against master documents)... 

Specifically in a PAI, a subset of the stability data is often reviewed by the regulatory agent to verify the results, to monitor the manufacturing records for the batch, and to review the methods used to collect the analytical test data and the systems used to control manufacturing and testing. 

The mercury content of the batteries for each year of manufacture can be calculated from historical manufacturing information held within the manufacturers records. These in turn can be used to determine the mercury contents of the alkaline and zinc carbon streams within the sample. 

A batch manufacturing record should be completed during the production of each batch of intermediate products and of active pharmaceutical ingredients. It should contain the relevant parts of the master formula and should include the following ... 

A batch manufacturing record should be completed during the production of each batch of intermediate products and of active... 

Batch manufacturing records should be retained for at least two years after completion of the clinical trial or at least two years after formal discontinuation or in conformance with the applicable regulatory requirement(s). 

Where any stage of manufacture is carried out in premises under other management or is entrusted to an outside contractor this fact shall be stated in the batch manufacturing records. 

In-process controls described in the batch manufacturing techniques must be carried out at the stated intervals. The results of those performed in the production area must be noted in the batch manufacturing record. At the same time, samples may be withdrawn and sent to the control laboratory. 

At the end of the operation, semi-finished products or semi-packaged products should be placed in suitable, properly labelled containers and accompanied by the batch manufacturing record, be consigned to a storage area of another manufacturing area or packaging room. An authorized person should assume responsibility for the product. 

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