Batch documentation

The objective briefly describes the purpose of the validation program. An additional objective is to provide supplemental manufacturing information beyond that recorded in the batch documents. 

The recording of production data will make it necessary to bring batch documentation into the radioisotope laboratory. Hence, it is important to have routines that minimize the risk for radioactive contamination of the documents and to ensure that any contaminated documents will not leave the controlled area. Today, the use of computers instead of paper documents in the laboratory leaves most of the paperwork outside the controlled area. 

All document types including more complex ones such as integrated batch documentation, illustrated SOPs. All document types must be stored in a neutral file format. 

Memos, master production and control records, SOPs, deviation reports, validation protocols, manual batch documentation, and many more. 

CAD drawings, SOP illustrations, scanned paper documents, label pictures for batch documentation. 

During the course of a broth fill, operator activity will benecessary as with routine manufacture. However, additional activities can be carried out to cover all permissible activities in order to provide evidence that product sterility is not affected. Such interventions should be planned and documented with the batch documentation. 

Many drug companies are using electronic means of verifying component names or item codes, receiving and control numbers, weights, or measures, and even the verification of component addition to a batch. There is a range of acceptability on the part of the FDA of electronic means of verification and batch documentation however, the validation of such... 

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. 

Annexure 3 Is the Certificate of Analysis issued by the supplier of the raw material, which was used in the batch document in the manufacturing documents submitted with the application, included ... 

In heat sterilization processes, a temperature record chart is made of each sterilization cycle with both dry and moist heat (i.e. autoclave) sterilizers this chart forms part of the batch documentation and is compared against a master temperature record (MTR). It is recommended that the temperature be taken at the coolest part of the loaded sterilizer. Further information on heat distribution and penetra-... 

Function does the programme match the assigned operational function (e.g. generate batch documentation, different batches of material used in a batch listed) ... 

Are you willing to provide product samples and batch documentation (on a confidential basis) when requested Yes No... 

In each case the report includes a summary of the design given in the protocol, the tests and procedures used in the studies with the appropriate limits for evaluation, the stability data tables with the necessary batch documentation, and finally the discussion of results and conclusions. 

Documentation Fill in the raw data sheet TLC II. Note the numbers of the balance used, TLC plate and reference substances. Record sample(s) weight and the quantity of the solvent. Cross the parameter s field to document the obtained result(s) and note the archive number(s) of the videoprints. Transfer the result(s) to the testing protocol. Operator and checker have to sign the raw data sheet with date and initials. All further sheets are to be paginated and signed on the last page. Finally all TLC raw data sheets are added to the batch documentation. 

Transfer the result(s) to the testing protocol. Operator and checker have to sign the raw data sheet with date and initials. All further sheets are to be paginated and signed on the last page. Finally all TLC raw data sheets are added to the batch documentation. 

Recordings from logbooks, batch documents, etc. (for plants in use)... 

Authorized Person. A person responsible for the release of batches of finished product for sale. In certain countries the batch documentation of a batch of finished product must be signed by an authorized person from the production department and the batch test results by an authorized person from the quality control department for batch release. 

Master Record. A document or set of documents that serve as a basis for the batch documentation (blank batch record). 

Information on the daily activities in each processing department should be available in addition to the batch documentation. 

Where aseptic operations are performed monitoring should be frequent using methods such as settle plates, volumetric air surface sampling (e.g., swabs and contact plates). Sampling methods used in operation should not interfere with zone protection. Results from monitoring should be considered when reviewing batch documentation for finished product release. Surfaces and personnel should be monitored after critical operations. 

In these cases, a re-assessment of the batch documentation and re-control of finished products should always be carried out The need for withdrawal of the given batch should be carefully considered taking into consideration criteria such as the disease, the type of seroconversions, the size of the pool, the time period between donation and seroconversion, and the nature of the product and its manufacturing method,... 

Equipment glassware, the external surfaces of product containers and other such materials must be disinfected before transfer from a contained area using a validated method (see 47 above). Batch documentation can be a particular problem. Only the absolute minimum required to allow operations to GMP standards should enter and leave the area If obviously contaminated, such as by spills or aerosols, or if the organism involved is an exotic, the paperwork must be adequately disinfected through an equipment pass, or the information transferred out by such means as photocopy or fax. 

Issued documents should not be handwritten. Reproduced or computer-printed documents should be clear and legible in the case of batch documents each should be initialled to indicate a verified issue. 

Master batch documents, standard operating procedures and other master documents having a direct bearing on product quality should be authorised by the person responsible for Quality Assurance or that person s delegate as well as by a responsible Production or other relevant Manager. 

Batches should be processed in accordance with master documents specified in Clause 533 and batch documents prepared and completed in accordance with Clauses 543-545. 

Where additional labels or pre-printed packaging materials are used during the packaging run, each additional issue should be shown on the batch document. 

STANDARD NAME A name assigned to a starting material that uniquely identifies it within the manufacturing establishment It is used to cite the material in specifications, on identity/status tags, in analytical reports, in stores records and in batch documents. It is chosen to avoid the possibility of confusion between similar-looking or similar-sounding names. 

CERTIFICATE OF MANUFACTURE (certificat de fabrication) A document issued by a vendor to a distributor or importer which attests that a specific lot or batch of drug has been produced in accordance with its master production document. Such certificates include a detailed summary of current batch documentation, with... 

A certificate of manufacture is considered as an acceptable alternative to complete batch documentation. Complete documentation is available on request in a timely manner. 

Where a distributor or importer employs a manufacturing certificate system, complete batch documentation is obtained on a periodic basis, which is not less than once per year. 

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