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Monday, 6-Jun-2016 01:20 Email | Share | | Bookmark
Effective Steps for Validation and 21 CFR Part 11 Compliance (CS

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.
In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:
o The US FDA
o European Medicines Agency (EMA)
o Good Manufacturing Practices (GMP)
o Good Laboratory Practices (GLP)
o Good Clinical Practices (GCP)
o All the Predicate Rules
Reasons for which Computer Systems need to be validated
The most important rationale for CSV, apart from its being required for the above stated, is that it is a very effective step towards ensuring the consistency of data and the quality of the product. This aside, CSV also helps in the protection of intellectual property (IP) by being a source that supplies data that is scientifically valid.

The 21 CFR Part 11 standard

The 21 CFR Part 11 standards, sometimes referred to as just Part 11, apply to the life sciences industry and consist of the criteria that the US FDA sets out for electronic records, electronic signatures and handwritten signatures. Its main purpose is to ensure that electronic records have the same equivalence as paper records as well as handwritten signatures.

Problems with Part 11 implementation
In the life sciences industry, the major challenges relating to adherence to Part 11 can be summarized as below:
o Ensuring the accuracy of data and the security of information
o Containing or preventing the loss of revenue from this exercise as well as to its business
o Properly and sufficiently assessing gaps in the systems.
The costs of not getting Part 11 right can be high for companies:
They can have their New Drug Application (NDA) denied; they can experience a potential delay in their manufacturing actives, or can invite any of these:
o Warning Letters
o 483
o Civil penalties
o Possible prosecution if the investigation shows up negligence on their part

What are the steps for carrying out an effective Computer Systems Validation?

The validation process for 21 CFR Part 11 compliance consists of these core elements:
o Comprehending the regulatory requirements
o Taking steps for ensuring compliance with CSV requirements in a cost-effective manner
o Carrying out testing of software and computer systems – initial and ongoing
o Ensuring that the bare minimum documentation that FDA inspectors will ask for are available
o Qualifying the IT systems network infrastructure and validating the network systems

Tuesday, 18-Jun-2013 09:41 Email | Share | | Bookmark
Understanding the calibration curve

To get an understanding of instrument calibration, we can think of it as being an essential phase in most measurement procedures. The calibration curve is a set of operations with which the relationship between the outputs of the measurement system (for example, the response of an instrument) and the accepted values of the calibration standards (for instance, the amount of analyte it has) can be established. Understanding the calibration curve is important because this is required in a large number of analytical methods.

How to go about a calibration curve?
At its most basic form, understanding the calibration curve has to begin with the preparation of a group of standards which contain a known amount of the analyte of interest. In this, the instrument response for each standard has to be measured. In addition, the relationship between the instrument response and analyte concentration has to be established. This relationship is then used to transform measurements made on test samples into estimates of the amount of analyte present.

The calibration process
In understanding the calibration curve, we have to know that a number of stages go into calibrating an analytical instrument. This is how a logical sequence of steps would look:
o Planning of the experiments;
o Making the relevant measurements;
o Plotting the results;
o Carrying out regression analysis on the data, which will help obtain the calibration function;
o Assessing the results of this regression analysis;
o Using the calibration function to estimate the values of the test samples;
o Evaluating the ambiguity of the values obtained


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Tuesday, 18-Jun-2013 09:39 Email | Share | | Bookmark
Technical file vs design dossier

One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what has given rise to the technical file vs design dossier.
Depends on class of device
At a basic level, there is a difference between the two: the medical device manufacturer must have technical documentation for each device. Called the conformity assessment annex of the MDD, IVD and AIMD directives; this is a basic requirement of these regulatory bodies and statues. The important element of the technical file vs design dossier aspect is that the terminology technical file/design dossier sometimes varies depending on whom the directive has come from, and the annex in which it is placed. This is why there is some confusion on this technical file vs design dossier matter.
The two terms are interrelated
The following description should give a perspective: by the term “technical file” is meant the description of the documentation that demonstrates the ways by which the device complies with essential requirements. Among these devices, some devices require a design examination. The Technical Construction File (TCF) of such devices is called a design dossier. This explains the fundamentals of the technical file vs design dossier debate.
Depends on the Notified Body
To recap, the technical file, which the MDD refers to as “technical documentation”, is a bunch of documents that the medical device manufacturer has to put in place and furnish to their Notified Body for assessment. This is to show that the medical device conforms to the Essential Requirements of the directive. While this much is clear, some Notified Bodies require different methods of documentation for certain class of medical devices. These are to be presented as a design dossier. This is what has given rise to some confusion about the technical file vs design dossier issue.

Contact Detail
43337 Livermore Common | Fremont| CA | USA | 94539

Tuesday, 18-Jun-2013 09:35 Email | Share | | Bookmark
Supplier quality audit training

Most medical device companies have auditors that assess the quality of the product from the supplier. This is the supplier quality audit. Supplier quality audit training is the training that is needed to be qualified to assess the quality of a product from the supplier. Auditors, regardless of whether they are from inside the organization or are external; have a need for this kind of training.
What are the attributes of an effective supplier quality audit training?
For a supplier quality audit training to be effective, it has to ideally combine theoretical and practical aspects of supplier quality audit. Auditing staff that undergo training must ideally be made to carry out a number of assignments in the area of regulatory compliance relating to supplier quality audit. This will give them enough knowledge of how the course aspects of supplier quality audit training work in real life.
What types of audits can supplier quality audit training help an auditor perform?
When proper supplier quality audit training is imparted, auditors in the organization or outside can perform the following types of audits:
o New supplier audits
o Existing supplier audits
o Time cycled audits
o Internal audits
o Audits specific to a task or cause
Areas of supplier audits
There are specific areas that supplier audits work in. The aim of supplier quality audit training is to identify these and help auditors carry the audits out in their respective areas:
o Regulatory
o Quality
o Operations
o Business
o The supplier audit process
Effective supplier quality audit training will help auditors carry out two important types of audit:
o Top-down, which is an ISO-type of audit that is concerned with recordkeeping and Quality System documentation
o Bottom up, a style of audit in which specific quality deficiencies are identified and rectified. This is usually referred to as the FDA type.

Contact Detail
43337 Livermore Common | Fremont| CA | USA | 94539

Tuesday, 18-Jun-2013 09:25 Email | Share | | Bookmark
Supplier qualification program

In the pharmaceutical and life sciences industries, a sound supplier qualification program is a must. It is an indispensable element of their very reputation. Many pharmaceutical organizations contract several of their manufacturing processes or even products to third parties. For this reason, the FDA considers the supplier as a logical extension of the manufacturer. In fact, it attaches so much importance to this area that it holds the pharmaceutical organization (the contracting company) responsible for the supplier’s behavior in relation to the manufacturer’s product

The FDA can inspect the supplier’s facility too
Since the supplier is considered a part of the manufacturer’s operations, the FDA reserves the right to inspect the supplier’s facility too, at the time of carrying out an inspection of the pharmaceutical organization. This being the importance of the supplier, it is imperative to chalk out an effective supplier qualification program that meets regulatory requirements.

Supplier evaluation
A supplier qualification program starts with supplier evaluation. Obviously, the supplier and his facilities have to be inspected according to predefined parameters. This will enable the pharmaceutical organization to clearly state the terms of the contract. The contract should ideally specify the conditions in which the pharmaceutical product is going to be made.

Key elements of a sound supplier qualification program
All the important aspects of a supplier qualification program have to be put in place, as should the kind and nature of control. There should be proper checking up of data that goes into the supplier qualification program. These are some of the aspects that need to be implemented:
o Establishment and maintenance of data that clearly describe or reference the specified requirements, among which quality requirements are very important
o Identification of the key elements of a strong, sustainable and successful supplier qualification program
o Signing of terms of the contract and making written agreements of the same, in which all the conditions of work will be clearly specified and ensure that the supplier meets the quality requirements consistently
o Ensuring that the supplier qualification program has processes that are important to quality. This should also define how conformance to manufacturer requirements will be monitored and verified.


Contact Detail
43337 Livermore Common | Fremont| CA | USA | 94539

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