Method Validation

According to 21CFR21-CFR-Part-11-FDA-Regulations, 601.2, as cited in the Guidance for Industry Document, Analytical Procedures and Methods Validation of Drugs and Biologics (July 2015)1,2, biologics license applications (BLAs) must include a full description of the manufacturing process, including analytical procedures that demonstrate the product meets prescribed standards of identity, quality, safety, purity and potency. The purpose of analytical method validation is to ensure that the methods used for assessing the quality of the product being manufactured complies with the established specifications and yield accurate, reliable, and reproducible results.2

Analytical Make-compendial-standards-universal-and-compulsory-to-improve-consistency-quality-of-supplements-says-USP-paper_strict_xxlmethods require validation, verification or re-validation in the following cases: 1) before initial use in routine testing, 2) when transferred to another laboratory and 3) if the conditions or parameters of the validated method have changed.3 Laboratories are expected to utilize compendial methods for testing, however a full validation is not required. A verification is done to ensure the laboratory can achieve the performance characteristics of the method and it is suitable for the intended analytical applications. Laboratories that require developing in-house methods, modifying compendial methods or using them beyond their intended use, should carry out full validation of the methods. A full validation includes establishing specifications and performance characteristic of the method and confirming it is suitable for the intended analytical applications.

An Analytical Method Validation Master Plan (AMVMP ) is prepared, when a project includes a range of different analytical validation activities. Although not all of the validation characteristics are applicable for all types of tests, typical validation characteristics are: specificity, linearity, accuracy, precision (repeat-ability, intermediate precision, and reproducibility), range, quantitation limit and detection limit. 2   Documentation is essential during a method validation, and includes a protocol, report and summary.  Once a method is validated, its performance is monitored and evaluated by trend analysis to determine if the method requires additional optimization, redevelopment and re-validation.Revalidation-logo

Written By: Jessica Bruno,  Consultant II

ICQ Consultants, Corp.

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  1. Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics, July 2015. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf (accessed on 22-Dec+2015)
  2. Food and Drugs, 21C.F.R. § 601.2 (2015) Available from http://www.ecfr.gov/cgi-bin/text idx?SID=136435444f0996cfa2ae3bbc2a232cc4&mc=true&node=se21.7.601_12&rgn=div8 (accessed on 22-Dec+2015)
  1. Ajay, S. and Rohit, S., Validation of Analytical Procedures: A Comparison of ICH, Vs Pharmacopeia (USP) Vs FDA, International Research Journal of Pharmacy (IRJP) 2012, 3(6).

Thank you for visiting with ICQ!

20160309_171213Everyone at ICQ would like to thank you 20160309_171239for visiting with us at the PDA Dinner “Evaluating Contract Manufacturing” on March 9th.  This event had a great turnout and was quite the success.  Thank you everyone for taking the time to attend and to all of those who dropped by and spoke with us.

ICQ Consultants, Corp.

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PDA Event “Evaluating Contract Manufacturing”

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Please join ICQ in attending the PDA’s event this evening.  “Evaluating Contract Manufacturing” will feature talks by Amnon Eylath and Andre Merza with the presentations concentrating on evaluating contract manufacturing for Biotech and Cell and Gene Therapy and Risk Analysis of Non-Conformances in Research Model Production.  This event will be located at the Boston/Woburn Hilton, 2 Forbes Rd. Woburn, MA 01801.  Registrations, cocktails and networking will begin at 5:30 and the event will continue until 9:00 P.M.  ICQ will be sponsoring this event and would please like you to drop by and say hello!

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ISPE CaSA 23rd Annual Life Sciences Technology Conference

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ICQ Consultants will be sponsoring a table at the 23rd ISPE CaSA Life Sciences Technology Conference in Raleigh, NC.  The event will take place on Thursday March 31st starting at 9:00 A.M. through 7:00 P.M. and will be held at the Raleigh Convention Center.   This event features many different speakers and will feature different companies exhibiting along with educational seminars, product demonstrations and a networking social event.  Please visit us at table number 203 and say hello!  We look forward to seeing you there.

ICQ Consultants, Corp.

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Five Keys to Problem Solving

WhyWhen an ICQ consultant is hired for a project, the main objective can appear fairly straight forward. Validate this system, write that protocol, etc… But in practice, helping a client achieve what they need never turns out to be that easy. Problems arise, and it’s at that moment that we need to be able to leverage both our own industry knowledge, and that of all of ICQ, to help remedy the situation. Every problem will be different, but there are some steps that will be needed regardless.

  1. Define the problem / Focus on the Root Causes (Not Symptoms)

There are many techniques for getting to the heart of a problem (flowcharts, cause and effect diagrams, root cause analysis, the 5 Why’s), but the important part is to be able to identify when a problem is a root cause or just a symptom of a deeper problem. There may be multiple root causes. Experience is key to being able to successfully define a problem. Make sure the right people are in the room, and if you feel as though something is being missed, remember that you work for a growing consulting firm that has years of collective experience. Leverage that experience.

  1. Look to turn off all Root Causes / Generate alternative Solutions

If we only look to resolve one root cause (for a problem with multiple root causes) the problem will likely resurface shortly, but perhaps appear to be a new or different problem. We want to find solutions that effectively “turn off” all the root causes. We also want more than one solution for any problem. This may be difficult for those of us with many years of experience, but showing patience in these early sets of problem solving can yield much higher dividends.

 

  1. Evaluate and Select Solutionssaas-software-solutions

Some things to consider when evaluating and selecting a solution might be:

  • What chance does a solution have to solve the problem without causing unanticipated problems? We might want to find simple solutions that affect as few contributing factors as possible. This will limit the impact to processes that are not currently experiencing a problem.
  • Will all individuals affected by the problem accept this solution? This may be a tough question to gauge, but if we have the right people in the room, we can find a solution that works for everyone.
  • Is it likely that the solution will be implemented? This goes hand in hand with the bullet above. If a solution will be difficult to implement, it’s more than likely that the problem will persist.
  • Does the solution fit within organizational constraints? Again, if a solution doesn’t work for the client, they are not going to implement it.

  1. Implement and follow up

Make sure to thoroughly plan the implementation of any solution: include goals, roll-out programs, CAPAs and plan the allocation of resources. Success will depend on getting the people affected by the problem involved in the solution. Feedback channels should be facilitated and welcomed as a way to continuously monitor the effectiveness of any change.

  1. Audit Results of Problem Solving

Once a problem has been solved within an operation, we should audit the affected process to make sure we have actually solved, not just contained, the problem. An assessment would also benefit the organization to figure out why a solution was effective or ineffective.Problem-Solved-Stamp-300x215

 

By effectively helping our clients to solve problems within their operations, we can create a good working relationship that goes beyond commissioning and qualifying systems.

Written By: Steve Graham, Consultant II

ICQ Consultants, Corp.

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