Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the most common approach to method validation is a one-time affair, there is need for guidance on how to implement continuous and consistent method performance.

Methods fail to perform as required or intended in the receiving laboratory because there is always the absence of an effective process for capturing and transferring the knowledge of those involved in the development. With too much emphasis on validation of the methods to meet regulatory requirements, the focus on what to do to make the process work during actual application seemed to be lost. It is to address this bottleneck that Quality by Design (QBD) and analytical methods took shape.

How do Quality by Design (QBD) and analytical methods make a difference?

QBD, in being “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”; emphasizes the importance of having predefined objectives built into the development process. An analytical method, which is an analytical procedure that includes all steps in the procedure, constitutes an important step in the QBD lifecycle approach. Together, Quality by Design (QBD) and analytical methods become an important component of the three-stage process of method validation, which are:

  • Stage one, which relates to method design
  • Stage two, which relates to method qualification, and
  • Stage three, which is about continued method verification

 Reference:

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=791903

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Process validation for medical devices

The FDA introduced the idea of process validation for medical devices with the idea of improving the quality of pharmaceuticals and medical devices. From its rudimentary form that was conceived in 1987, process validation for medical devices has undergone changes to accommodate more types of devices and more processes into the validation.

Why is process validation for medical devices necessary?

In simple terms, validation is the ability of a medical device to demonstrate that a procedure, process and activity will consistently lead to the expected results. For the FDA; process validation for medical devices is all about establishing documented evidence which will offer a high degree of assurance that a specific process will consistently produce a medical device product that meets its pre-determined specifications and quality characteristics.

Process validation for medical devices is a requirement of the current GMP regulations for medical devices, 21 CFR Part 820 and is applicable to the manufacture of medical devices.

Factors

A host of factors influences the quality of a product in medical device manufacturing. Some of these are:

  • Adequate product and process design
  • Control of the process
  • In-process and end-product testing
  • Selection of quality parts and materials

The guidelines published by the FDA provide a framework for medical device manufacturers to build a holistic approach to process validation for medical devices. This is broad in nature, since the particulars of process validation vary from one manufacturer to the other because of many factors, such as

  • The nature of the medical product (e.g., sterile vs. non-sterile)
  • The complexity of the process
  • The local regulatory requirements
  • The age of the product (e.g., new invention vs. similar to an existing product)

The FDA recommends that the manufacturer:

  1. Prepare a written validation protocol  which specifies:
    1. The procedures to be conducted and the data to be collected
    2.  Purpose of data collection
    3. A sufficient number of process repetition to demonstrate reproducibility
    4. An accurate measure of variations during repeated process runs
    5. The test conditions that include best case and worst case scenarios called as “most appropriate challenge” conditions
    6. Validation documentation requirements to include evidence of the suitability of materials and the performance and reliability of equipment and systems
    7. Monitor and document key process variables and analyze the data collected to establish:
      1. The variability of process parameters for individual runs
      2. Whether or not the equipment and process controls are adequate to assure that product specifications are met
      3. Utilize finished product test data and in-process test data to obtain quality attributes and in establishing variability
      4. Where finished (or in-process) testing cannot adequately measure certain attributes, process validation should utilize the details of each system in production and by document the observed results

Reference:

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070336.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122439.htm

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Pharmaceutical production batch record review

We can understand pharmaceutical production batch record review as meaning the controls and processes that pharmaceutical organizations have to build into the batch records of pharmaceutical products they manufacture. This is a means to ensuring that products meet compliance standards and are easy to detect whenever a problem arises from a sample in the batch or in the entire batch.

What does the 21 CFR 211.100 (a) say?

21 CFR 211.100 (a) is clear in its expectations. This and related subsections lay out the process by which pharmaceutical production batch record review has to be done. It states that all requirements have to written down in a prescribed format. The aim is to ensure that the core qualities of the drug relating to its molecule, such as the strength, quality, purity and identity are adhered to in every batch.

WHO requirements

The World Health Organization (WHO) lists the requirements for pharmaceutical production batch record review. These are the main points that go into it:

Pharmaceutical production batch record review consists of reviewing production and quality control records being made part of the approval process of batch release. Whenever there is the slightest deviation or failure on the part of any batch to meet its specifications; this should be properly and completely investigated. To ensure the quality of pharmaceutical production batch record review; the WHO states that the investigation can extend to other batches of the same product if necessary. On any observation and action taken, there should be a written record created of the investigation. This record should include the conclusion and details of the follow-up action that was taken.

The WHO also states that retention samples from each batch of finished product should be kept for at least one year after the expiry date. These have to be kept in the prescribed methods and conditions. Pharmaceutical production batch record review requirements state that where starting materials are concerned, the retention period is two years from the date of expiry.

References:

http://apps.who.int/medicinedocs/en/d/Js5517e/20.4.17.3.html#Js5517e.20.4.17.3

http://pharmaceuticalvalidation.blogspot.com/2010/03/batch-manufacturing-record-review.html

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Online compliance training

Compliance training is a vast area of continuing professional education. Professionals in any industry that requires compliance with set standards –this could mean almost any industry or profession –require compliance trainings. Compliance training is required in all these areas, and professional organizations offer these with the help of experts in the field.

Online compliance training –a different medium

Given the nature of the compliance field, online compliance training has gained importance. While the professional requirement is one reason, the phenomenal growth of the Internet has brought about this new medium of compliance training. Most online compliance trainings are fueled by two important factors:

a)     The need for training, given that professionals in any compliance-related profession need to keep updating their skills from time to time to stay abreast of the latest happenings in their industry, lack of whose knowledge can stunt their career growth;

b)     The paucity of time to attend full-fledged, day-long interactions or the lack of need for such elaborate knowledge sharing. Many a time, a pinpointed discussion on a specific and focused topic will serve the purpose.

What do you need to look out for?

A professional who seeks online compliance training will obviously need to look mainly for the topic that is being covered. The website of any provider of online compliance training will have a list of their trainings. See if what they are offering is what you are looking for. These companies know what professionals are looking for at any point of time, so they are usually not off the mark by a huge margin. Yet, just take a look at what courses they have.

Next, look out for the profile of the experts. Experts of these online compliance training courses should ideally be people who have been in the industry for a long time or have been associated with it in some or another way. If you are convinced about their credentials and feel that the exact topic you are looking for is not available, you could possibly ask the provider of online compliance training if they could arrange for a course that is more suitable for you.

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Medical device quality agreement

In the medical devices, pharmaceutical and life sciences industries, there is a growing tilt towards contract manufacturing. This is done by organizations that perceive benefits in the form of increased ROI and operational ease. In the process of getting these works carried out, organizations have to ensure that their quality and other traits are maintained. In order to make sure that these are present, a medical device quality agreement becomes necessary.

What is a medical device quality agreement?

We can understand a medical device quality agreement as a formal document that defines the terms of engagement between the supplier and the contractor (sponsor) the sets out the ways in which pre-defined quality processes are going to be laid out and monitored. This is necessary as medical devices and products of the pharmaceutical and life sciences require a high degree of scientific precision, which have to be ensured no matter where and by whom they are manufactured. The product has to also meet regulatory requirements, since this cannot be compromised on.

Shared responsibility

The foundation of a medical device quality agreement is the level of similarity the product brings when it is manufactured by the supplier. Since a medical device quality agreement involves both the parties, its benefits and pitfalls are mutual and shared. The reputation of both the supplier and the sponsor is at stake, and both are equally responsible for the product outcome and quality. The medical device quality agreement should state the extent to which this is going to operate during the contract.

In which areas are medical device quality agreements done?

A medical device quality agreement is done in relation to the following among related areas:

  • Maintenance, qualification and validation activities
  • GMP audits by third parties
  • Label printing
  • Release activities
  • Storage and transport

References:

http://www.mastercontrol.com/newsletter/quality_agreements_1209.html

http://www.asqlongisland.org/seminars/QualityAgreements-Bailey2005.pdf

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Contamination control plan

A contamination control plan is one of the essential practices of cGMP.  Having it in place is a prerequisite for a validated facility, because lack or absence of it is one of the primary reasons for the issuance of 483’s. Among these, the FDA cites lack of sterility assurance as the most important factor for 483’s. This is defined as the lack of ability on the part of the manufacturer to ensure and document sufficient protection to safeguard against unforeseen events. A contamination control plan has a description of the policies and procedures that go into manufacturing products under controlled conditions.

Where should it be included?

Since the contamination control plan covers all aspects of the facility; it is an indispensable part of the validation plan. The manufacturer’s master validation plan should have in it a proper, convincing and demonstrable contamination control plan. All the factors that go into maintaining the state of control of the validated facility, such as sanitization, cleaning and sporicide treatment should be clearly illustrated in the contamination control plan.

Which industries require a contamination control plan?

Traditionally, a contamination control plan is necessary in the regulated industries such as medical devices, pharmaceuticals, healthcare and diagnostics.

Which tools are important in a contamination control plan?

Root Cause Analysis and Failure Mode Evaluation Analysis (FMEA) are the important tools that are applied in drawing up a contamination control plan.

Reference:

http://microbiologynetwork.com/content/file/JVT_2012_v18n2_The-Contamination-Control-Plan-in-Facility-Validation.pdf

 

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Conducting a clinical laboratory session

For an aspiring clinician, the most important lesson is conducting a clinical laboratory session. What does conducting a clinical laboratory session mean? Lying at the core of health technology programs; a clinical laboratory session is meant to familiarize students of laboratory technology with real life examples of what they get to do when they pursue their careers.

Real-life environment

Reputable institutions that teach clinical laboratory classes are either attached to a high class, well-equipped medical center or have access to one. The aim of being in such proximity is that as mentioned above; conducting a clinical laboratory session has to be as close to real life as possible, since these are the environments in which the students will work once they become full-fledged professionals in the future.

Mix of theory and practice

In most clinical laboratory sessions, there will be a regular faculty member who carries oversight of the session and supervises the class. Under her or his guidance, the first steps to conducting a clinical laboratory session are taken. The training will consist of both theory and practice, because health technology programs require the use of both. Students will have to practically implement what they learn theoretically. Once they start their careers, there is need to apply what they have learnt. This is why conducting a clinical laboratory session has to be onsite, meaning that it should ideally be done in healthcare settings.

References:

http://www.bgsu.edu/downloads/bgsu/file59697.pdf

 

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