Thursday, May 29, 2008
Requirements for Pregnancy and Lactation Labeling
Today FDA has invited for public comment for the proposed amendment of its regulations concerning the format and content of the ``Pregnancy'', ``Labor and delivery'', and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products
Upcoming web seminars
Develop, Execute and Enforce an Effective Validation Master Plan - June 17 , 2008
The VMP is a document that has never been mandatory, but can be one of the first documents a regulator will ask to view but most companies are using them. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.
Risk-Based Software V&V - FDA,GAMP, 14971 - June 17, 2008
this webinar will explain how to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources
Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements June 19, 2008
The VMP is a document that has never been mandatory, but can be one of the first documents a regulator will ask to view but most companies are using them. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.
Risk-Based Software V&V - FDA,GAMP, 14971 - June 17, 2008
this webinar will explain how to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources
Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements June 19, 2008
Sunday, May 4, 2008
FDA Compliance General (Med device, Pharma, Biotech)
Q - How can you defind a varying load in sterilant?
Answer -Usually the load selection is done by reviewing all the products in the sterile family and making a judgement. It may be helpful to get a bunch of product samples on a table in the conference room, and have a meeting with the people who are involved with the sterilization or have knowledge of sterilization. Usually, the selection is then made based on a combination of items ---- products that may be the heaviest, densest products, or those with the most complicated design, or with the most difficult tubings, pathways, internal lumens, closed-off tubings etc., are there any gauzes or cottons that may have high bioburdens and absorb more EO than metals or glass? Also, how much packaging material is used on the different products, and do the packaging materials absorb humidity & EO, or do the packaging materials restrict the exchange of heat, EO, humidity. You then also need to look at the case configuration & pallet configuration --- are there sterilizer loads or load configurations that will be particularly resistatant to heat-up, or will absorb abnormal amounts of EO?
Document the results of the product review meeting, so it can be added to your validation protocol.
If you cant decide which product or load configuration, you may need to run a few fractional/sublethal cycles at your sterilizer, with candidate loads, to see which load has the worst heat&humidity profiles, and/or which loads show the most survivors (fractional cycle) with sample test products that have internal BIs. This may take longer and cost more than originally planned for the validation, but it is important that it gets done right the first time.
View related training - Ethylene Oxide Sterilizer Validation: Basic Requirements
Answer -Usually the load selection is done by reviewing all the products in the sterile family and making a judgement. It may be helpful to get a bunch of product samples on a table in the conference room, and have a meeting with the people who are involved with the sterilization or have knowledge of sterilization. Usually, the selection is then made based on a combination of items ---- products that may be the heaviest, densest products, or those with the most complicated design, or with the most difficult tubings, pathways, internal lumens, closed-off tubings etc., are there any gauzes or cottons that may have high bioburdens and absorb more EO than metals or glass? Also, how much packaging material is used on the different products, and do the packaging materials absorb humidity & EO, or do the packaging materials restrict the exchange of heat, EO, humidity. You then also need to look at the case configuration & pallet configuration --- are there sterilizer loads or load configurations that will be particularly resistatant to heat-up, or will absorb abnormal amounts of EO?
Document the results of the product review meeting, so it can be added to your validation protocol.
If you cant decide which product or load configuration, you may need to run a few fractional/sublethal cycles at your sterilizer, with candidate loads, to see which load has the worst heat&humidity profiles, and/or which loads show the most survivors (fractional cycle) with sample test products that have internal BIs. This may take longer and cost more than originally planned for the validation, but it is important that it gets done right the first time.
View related training - Ethylene Oxide Sterilizer Validation: Basic Requirements
FDA Documentation Compliance
Q - What would the FDA think about test documents with actual results typed in instead of being handwritten?
Details - With global teams we have to do a lot of scanning of documents for pre and post execution review, some would like to type the results and signatures so they can be reviewed more easily and eliminate the need to scan/fedex documents. These could not be technically consider 'electronically' completed as the software storing the documents does not have electronic signature capability.
What Expert Says - FDA considers the original data the be the record(s) you generate during the execution of the protocol. If you're handwriting data as you execute the steps of the protocol, then the handwritten record would considered the original and you must maintain it as such. If you want to transcribe the handwritten data, you could create a validated/qualified transcription process, however, you would still maintain the handwritten original. Additionally, the electrnoic transcriptions must also be maintained as auditable electronic records (since you're likely using the transcription to make pass/fail decisions) so there would be absolutely no busiess advantage since you're essentially doubling the work of record maintenance. Regarding this statement,"These could not be technically considered 'electronically' completed as the software storing the documents does not have electronic signature capability," this is a common misconception that I've seen before. An electronic record isn't defined by having an electronic signature, it's defined by the source/use of the data (ie to make GxP decisions). An electronic record can be approved as easily by a handwritten signature as an electronic signature, however, the electronic record must still have appropriate access controls and audit trail.
Overall, it sounds like you have a handwritten protocol execution process that you want to streamline for business reasons. If that's the case, then I recommend one of two paths: either 1) Continue to execute your protocols by hand and improve your document scanning/imaging capability, or 2) go totally electronic with a validated system like ValGenesis. I would not recommend using a transcription process because it's costly and you still have to maintain the original record.
Related Training - Introduction to Good Documentation Practices for FDA-Regulated Industries
Details - With global teams we have to do a lot of scanning of documents for pre and post execution review, some would like to type the results and signatures so they can be reviewed more easily and eliminate the need to scan/fedex documents. These could not be technically consider 'electronically' completed as the software storing the documents does not have electronic signature capability.
What Expert Says - FDA considers the original data the be the record(s) you generate during the execution of the protocol. If you're handwriting data as you execute the steps of the protocol, then the handwritten record would considered the original and you must maintain it as such. If you want to transcribe the handwritten data, you could create a validated/qualified transcription process, however, you would still maintain the handwritten original. Additionally, the electrnoic transcriptions must also be maintained as auditable electronic records (since you're likely using the transcription to make pass/fail decisions) so there would be absolutely no busiess advantage since you're essentially doubling the work of record maintenance. Regarding this statement,"These could not be technically considered 'electronically' completed as the software storing the documents does not have electronic signature capability," this is a common misconception that I've seen before. An electronic record isn't defined by having an electronic signature, it's defined by the source/use of the data (ie to make GxP decisions). An electronic record can be approved as easily by a handwritten signature as an electronic signature, however, the electronic record must still have appropriate access controls and audit trail.
Overall, it sounds like you have a handwritten protocol execution process that you want to streamline for business reasons. If that's the case, then I recommend one of two paths: either 1) Continue to execute your protocols by hand and improve your document scanning/imaging capability, or 2) go totally electronic with a validated system like ValGenesis. I would not recommend using a transcription process because it's costly and you still have to maintain the original record.
Related Training - Introduction to Good Documentation Practices for FDA-Regulated Industries
Q - Is it ok to dispose of red-lined documents after completion of a promotional review ? (CFR21, Part 11)
Answer - It is not necessary to retain intermediate or draft versions of any document that is required by a predicate rule. You have a document management system in place that requires review and approval of all changes and that a revision history is maintained. Likewise, your system should ensure controlled access to the approved versions and that no unauthorized changes are allowed. Your overall SOP for document control should stipulate that draft or red lined versions of documents will not be retained.
Saturday, May 3, 2008
FDA Validation compliance
Q - difference between GMP & cGMP ?
Ans -Essentially GMP and cGMP are one and the same with one significant distinction; the “c” denotes current. It is my understanding that the FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products. An added benefit of prefixing their legislation is that the FDA have made their standards immediately identifiable; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). By saying that firm X employs cGMP indicates that they are following 21 CFR 210 and 211 and no other.
Also i have listed some of the good trainings which you can view online
Related Training -
Efficient Computer System Validation - 10 Easy Steps
Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Master Planning for Computer System Validation
Risk Based Validation of Software and Computer Systems
Assessment of Computer System Risk as a Basis for Validation
Verification vs. Validation
Ans -Essentially GMP and cGMP are one and the same with one significant distinction; the “c” denotes current. It is my understanding that the FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products. An added benefit of prefixing their legislation is that the FDA have made their standards immediately identifiable; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). By saying that firm X employs cGMP indicates that they are following 21 CFR 210 and 211 and no other.
Also i have listed some of the good trainings which you can view online
Related Training -
Efficient Computer System Validation - 10 Easy Steps
Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Master Planning for Computer System Validation
Risk Based Validation of Software and Computer Systems
Assessment of Computer System Risk as a Basis for Validation
Verification vs. Validation
Q -how do you calibrate a thermometer ?
Ans -for calibration of the thermometer put thge standard and the TUC (both should be of same range)in the silicon oil bath and slowly raise the temperature and check the temperature difference between both of thew thermometers and note the difference,set some criteria for the temperatiure difference
Q -Please explain the worst case in cleaning validation with examples.
Ans -worst case in cleaning validation is the study of product preparing the matrix in part a, b, c, part a as selection of product based on its solubility and min. strength, part b mean mac calculation by considering the selected product in part a, and part c mean equipment train contact surface area calculation, swab aea or rinse volume, and calculating for ppm allowable limit per equipment per product in respective mfg. area.
in other ways it can be studied by grouping the products in to the matrix as high to high, low to low , low to high and high to low.
Related Training - Cleaning Validation - Chemical & Microbiological Aspects
Download Free compliance products
Here is a selection of free compliance products from different providers. Click on the links below to download.
Capability of detection - Part 1: Terms and definitions - Corrigendum
Microlens array - Part 1: Vocabulary - Corrigendum
Technical Corrigendum 1 to ISO 1998-5:1998 Document Number: ISO 1998-5/COR1:1999
Information and documentation - Presentation of catalogues of standards Document Number: ISO 7220/Cor1:2001
Linear calibration using reference materials Document Number: ISO 11095:1996
Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method Document Number: ISO 5725-5/Cor1:2005
For more products click here
Capability of detection - Part 1: Terms and definitions - Corrigendum
Microlens array - Part 1: Vocabulary - Corrigendum
Technical Corrigendum 1 to ISO 1998-5:1998 Document Number: ISO 1998-5/COR1:1999
Information and documentation - Presentation of catalogues of standards Document Number: ISO 7220/Cor1:2001
Linear calibration using reference materials Document Number: ISO 11095:1996
Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method Document Number: ISO 5725-5/Cor1:2005
For more products click here
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