Entries Tagged as 'GMP'
Poor Data Quality in Clinical Trials
Jane Barrett discusses data quality as she addresses the question raised by DIA’s 2nd European Clinical Forum: Is 90% of data rubbish?
Jan 1, 2009
By: Jane Barrett
Applied Clinical Trials
Is 90% of All Data Collected Rubbish?
Is 90% of all data collected rubbish? A provocative keynote debate at the recent DIA 2nd European Clinical Forum explored this question.
Journal:
Applied Clinical Trials, Jan 1, 2009
What information is contained in Batch Processing Records?
A batch processing record is required for each batch of material produced. The review of this document is a critical part of the batch release process. A master document should be prepared for each batch size that will be manufactured. It will be taken from the relevant parts of the master formula as discussed previously.
The first step in this document must be the area clearance check. This is a record of the previous product and batch processed in the area and a confirmation that all the material and documentation relating to that batch has been removed. It is also confirmation that all the cleaning has been carried out correctly. This check must always be documented. [Read more →]
Things to be in Mind preparing documentation
· All documents should be unambiguous with a title and a clear statement of purpose.
· They should contain clear, numbered references to each activity.
· They should have sufficient space to record relevant data.
· They should be easy to check and all relevant activities should be recorded on them.
· It is possible for some of the documents to be combined, but generally they should be separate. [Read more →]
What information should be contained in labels?
There are two classes of labels. There are the finished product labels, which must meet national drug regulatory authority requirements as specified in the marketing authorization. Then there are the labels used within the factory to control processes.
Labels are required for all containers of materials, whether for starting materials, intermediates or finished products; there must be sample labels and labels that are applied to materials that have been sampled; there must also be labels for all process equipment and for premises that are in use for manufacturing. The labels should be clear and unambiguous. Where possible, it is advisable for companies to use colours to indicate status (quarantine, accepted, rejected, cleaned or dirty).
Companies generally have their own systems for internal labelling that define what information is carried, but for finished products, there is a national requirement. Responsibility for labelling varies with company practice, but the process is generally overseen and controlled by the QC department. QC staff are responsible for issuing status labelling when a material has been approved or rejected. The responsible production and/or QC staff should sign labels stating that equipment is clean and available for use.
Reference standards (both primary and secondary) must be appropriately labelled and the issue of these must be controlled.
Documentation Approval and Distribution
· Documents should be designed, prepared, reviewed and dated by appropriate authorized persons. No document should be changed without authorization.
· Any alteration made to a document should be signed and dated; the alternation should permit the reading of the original information. Where appropriate the reason for the alternation should be recorded.
· Distribution of documents needs to be carefully controlled in order to ensure that the most up-to-date version is always being used. There should be a distribution list, if appropriate, attached to the document.
· Unauthorized photocopying of original documents should be actively discouraged. Some companies manage this by having part of the front page printed in colour, or by using an official stamp or other means of identification.
· There should be an SOP for distribution, retrieval and preparation of documentation. A document register is required. This ensures that change control over all documents is properly managed.
Purpose of documentation
Documentation is an essential part of QA and relates to all aspects of GMP. The pharmaceutical industry must have a good document framework (infrastructure). It is important for a manufacturer to get the documentation right in order to get the product right.
•They are used to define specifications for materials and for methods of manufacture and control.
•They ensure that everyone concerned with manufacture and QC knows what to do, how and when to do it.
•They allow decisions to be taken on batch release.
•They provide an audit trail, which is particularly important in the case of suspect batches.
API Manufacturing & Management Practices
Some general managers may think they need only an accountant and an attorney to run a business, but if you have risen through the technical ranks, you know a lot more insight is required to successfully manage an API facility. Sure, accounting and legal services are two very important items in your toolbox. Both functions tend to operate in a conservative fashion and serve to mitigate or limit risk. However, businesses do not tend to grow without taking risks. General Patton was quoted as saying, “Take calculated risks. That is quite different from being rash.”
Journal:
contractpharma .January / February 2007.
Copyright:
©Advanstar Communications. All rights reserved.
Process Validation How Much to do and When to do?
Journal:
BioPharm International, October 2002
Copyright:
BioPharm International
Translator
By N2H