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Returns 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 lessDocument Retention
Hi Lavanya, You can choose the media which you use to produce and store your documentation. Duplication is not required. You don't have to print digital data and store it digitally. If you use a complex digital system, you need to validate it and ensure it functions according to the ALCOA+ requiremeRead more
Hi Lavanya,
You can choose the media which you use to produce and store your documentation. Duplication is not required.
You don’t have to print digital data and store it digitally.
If you use a complex digital system, you need to validate it and ensure it functions according to the ALCOA+ requirements.
You can find more information about the requirements in the EudraLex, Volume 4, Chapter 4: Documentation.
See lessCleaning Validation
Hi Neda, Cleaning validation is always required, even for single products lines. You need to perform thorough cleaning between batches. You must avoid contamination of new batches: - Old batches - Raw materials of old batches That way, if you have an issue with one batch, you don't extend it to theRead more
Hi Neda,
Cleaning validation is always required, even for single products lines. You need to perform thorough cleaning between batches.
You must avoid contamination of new batches:
– Old batches
– Raw materials of old batches
That way, if you have an issue with one batch, you don’t extend it to the next ones.
I hope that helps.
See lessISO 9001 and QMS
Hi Nadia, ISO certification is not required for the PQMS, as you get your manufacturing licensing from government agencies. The PQMS is based on ISO9001 operates but operates on a higher level. You can learn more about the requirements of the PQMS in ICH Q10.
Hi Nadia,
ISO certification is not required for the PQMS, as you get your manufacturing licensing from government agencies.
The PQMS is based on ISO9001 operates but operates on a higher level.
You can learn more about the requirements of the PQMS in ICH Q10.
See lessGXP requirements for Cold Chain Monitoring
Dear Harikrishnan, What information exactly do you require about cold chains? Do you need resources? And for which regulatory area?
Dear Harikrishnan,
What information exactly do you require about cold chains? Do you need resources?
And for which regulatory area?
See lessSupplier Qualifications
My first instinct would be to say - don't bother with this supplier and look for an alternative. You cannot run a production without a backup anyways—especially critical materials. What happens if the supplier shuts down, or you must disqualify it because of quality issues? But if you really have noRead more
My first instinct would be to say – don’t bother with this supplier and look for an alternative. You cannot run a production without a backup anyways—especially critical materials.
What happens if the supplier shuts down, or you must disqualify it because of quality issues?
But if you really have no alternatives at the moment, I would suggest conducting a risk analysis. You need to convenience yourself and the regulators that the deviations from your procedures and lack of documents won’t impact the product’s quality.
Additionally, make sure you test each batch for the full monograph if it’s a raw material.
I hope that makes sense for you.
PQS and QMS
If by PQS you mean - Pharmaceutical Quality System, it means the same as QMS. The terms QMS and PQS can be used interchangeably, but when you say PQS, everybody knows you are talking about pharma. QMS= Quality Management System. It is a general term and usually follows the foundations of the ISO9001Read more
If by PQS you mean – Pharmaceutical Quality System, it means the same as QMS.
The terms QMS and PQS can be used interchangeably, but when you say PQS, everybody knows you are talking about pharma.
QMS= Quality Management System. It is a general term and usually follows the foundations of the ISO9001 standard.
The PQS, however, is much more robust and strict than ISO9001, as it must comply with laws and regulations. Therefore, many things are “good to have”, and ISO QMS are mandatory in the PQS.