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Assignment Dosage Form Design

The document discusses requirements for batch manufacturing records for APIs and intermediates. It states that batch records should include complete production and quality control information for each batch, reference the appropriate master production document, and be numbered, dated, and signed. It lists details that must be documented for each significant manufacturing step, including identities, weights and measures of materials, process parameters, sampling, signatures, yields, packaging and labeling information, any deviations, and release testing results. It also notes that procedures should exist to investigate critical deviations or batches that fail to meet specifications.

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Sheetal Giri
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208 views3 pages

Assignment Dosage Form Design

The document discusses requirements for batch manufacturing records for APIs and intermediates. It states that batch records should include complete production and quality control information for each batch, reference the appropriate master production document, and be numbered, dated, and signed. It lists details that must be documented for each significant manufacturing step, including identities, weights and measures of materials, process parameters, sampling, signatures, yields, packaging and labeling information, any deviations, and release testing results. It also notes that procedures should exist to investigate critical deviations or batches that fail to meet specifications.

Uploaded by

Sheetal Giri
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Assignment Dosage Form Design

Submitted By Pushpanjali Giri Roll.no:18 th 4 Year, &7th Semester

Submitted To -

BATCH MANUFACTURING RECORDS:


Batch manufacturing records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch. The batch manufacturing record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction. If the batch manufacturing record is produced from a separate part of the master document, that document should include a reference to the current master production instruction being used. These records should be numbered with a unique batch or identification number, dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number is allocated. Documentation of completion of each significant step in the batch manufacturing records should include: Dates and, when appropriate, times; Identity of major equipment (e.g., reactors, driers, mills, etc.) used; Specific identification of each batch, including weights, measures, andbatch numbers of raw materials, intermediates, or any reprocessedmaterials used during manufacturing; Actual results recorded for critical process parameters; Any sampling performed;

Signatures of the persons performing and directly supervising or checkingeach critical step in the operation; In-process and laboratory test results; Actual yield at appropriate phases or times; Description of packaging and label for intermediate or API; Representative label of API or intermediate if made commerciallyavailable; Any deviation noted, its evaluation, investigation conducted (if appropriate) or reference to that investigation if stored separately; and Results of release testing. Written procedures should be established and followed for investigating critical deviations or the failure of a batch of intermediate or API to meet specifications. The investigation should extend to other batches that may have been associated with the specific failure or deviation.

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