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See lessHow to Write a Salutation in a Personal Letter?
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See lessIs Airlocks required for MLT and culture handling room?.
It is Completely depends on the design . There is no specific requirement to have a MAL for Specific Rooms . The main aim to prevent the Contamination/ Cross Contamination. In the culture handling room ( GPT test room ) should have a segregated AHU to prevent Cross Contamination.
It is Completely depends on the design . There is no specific requirement to have a MAL for Specific Rooms . The main aim to prevent the Contamination/ Cross Contamination.
In the culture handling room ( GPT test room ) should have a segregated AHU to prevent Cross Contamination.
See lessReturns Vs Recalls
Dear Nadia, a recall is an action which the manufacturer of the pharmaceutical product initiates, mostly because of a quality issue. In this case, one or more batches needed to be sent back. The authorities need to be informed as well. A product return is an action done by a customer. This can be quRead more
Dear Nadia,
a recall is an action which the manufacturer of the pharmaceutical product initiates, mostly because of a quality issue. In this case, one or more batches needed to be sent back. The authorities need to be informed as well.
A product return is an action done by a customer. This can be quality-related or not. If it is quality-related, the manufacturer should conduct an investigation and if needed initiate a recall.
See lessHow many containers of each component from each shipment must a firm sample and test to comply with the CGMP requirements for identity testing? Do the CGMPs permit the identity test on a pooled, or composite, sample of multiple containers?
The CGMPs address the issue of sample compositing directly but only in the context of individual container sampling. Section 211.84(c)(4) explicitly prohibits compositing samples taken from the top, middle, and bottom of a single container when such stratified sampling is considered necessary (as miRead more
The CGMPs address the issue of sample compositing directly but only in the context of individual container sampling. Section 211.84(c)(4) explicitly prohibits compositing samples taken from the top, middle, and bottom of a single container when such stratified sampling is considered necessary (as might be the case when moisture content needs to be controlled, particularly when only a portion of a container may be used in a drug product batch). The preamble for § 211.84(c)(4) explains further that there “is no general prohibition… on compositing samples [from single containers] where such compositing would not mask subdivisions of the sample that do not meet specifications” (see 1978 preambleExternal Link Disclaimer, paragraph 231).
Testing individual samples from multiple containers provide a high level of assurance and are consistent with CGMP. Testing a composite model for identity could satisfy the CGMP regulations (§§ 211.84 and 211.160) but only if a manufacturer demonstrates either that the detection of a single non-conforming container is not masked by compositing or that an additional test(s) routinely performed on the composite sample ensures that all containers sampled contain the same material. Thus, a purity assay on a composite sample prepared by mixing equal aliquots from each container may be acceptable, provided such a test is sufficiently sensitive to reveal the presence of a single non-conforming container.
References:
The preamble to the Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding regulations (43 FR 45014, Sept 29, 1978)
21 CFR 211.82: Receipt and storage of untested components, drug product containers, and closures
21 CFR 211.84: Testing and approval or rejection of components, drug product containers, and closures
21 CFR 211.160: General requirements (Laboratory Controls)
FDA Guidance for Industry, 2000, ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances [Text or PDF]
FDA Guidance for Industry, 1999, ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products [PDF]
See lessIs it acceptable to simply segregate products of a common therapeutic classification
Manufacturers cannot just segregate everyday products from other product types to deal with the risk to patient and animal safety. Although this may prevent contamination of other product classes, it does not address cross-contamination within product classes. This should include implementing appropRead more
Manufacturers cannot just segregate everyday products from other product types to deal with the risk to patient and animal safety. Although this may prevent contamination of other product classes, it does not address cross-contamination within product classes.
This should include implementing appropriate organisational and technical control measures to prevent contamination between such products within product-specific HBELs.
See lessWhat are the Specs and Requirements for conducting visual inspection as per Q&A 7?
When applying visual inspection to determine the cleanliness of equipment, manufacturers should establish the threshold at which the product is readily visible as a residue. This should also consider the ability to visually inspect the equipment, for example, under the lighting conditions and distanRead more
When applying visual inspection to determine the cleanliness of equipment, manufacturers should establish the threshold at which the product is readily visible as a residue.
This should also consider the ability to visually inspect the equipment, for example, under the lighting conditions and distances observed in the field. Visual inspection should include all product contact surfaces where contamination may be held, including those that require dismantling of equipment to gain access for inspection and by use of tools (for example, mirror, light source, boroscope) to access areas not otherwise visible.
Non-product contact surfaces that may retain products that could be dislodged or transferred into future batches should be included in the visual inspection. Written instructions specifying all areas requiring visual inspection should be in place, and records should confirm that all inspections are completed. Operators performing visual inspection need specific training in the process, including periodic eyesight testing. Their competency should be proven through a practical assessment.
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