ICH guideline Q7

As an ICH guideline, Q7 takes a primary position. ICH guideline Q7 relates to the whole range of Good Manufacturing Practice (GMP) for a human drug’s Active Pharmaceutical Ingredient (API) covering the US, the EU and Japan. Originally called the ICH Q7A; these guidelines were issued in November 2000 by the International Conference on Harmonization (ICH).

Covers a range of topics

Being an important ICH guideline,Q7 covers a whole range of topics. Quality management, personnel qualifications and materials management are some of these. ICH guideline Q7 also covers the following:

  • Documentations and records;
  • Materials management;
  • Production and in-process controls;
  • Packaging and identification labeling of APIs and intermediates;
  • Storage and distribution;
  • Laboratory controls;
  • Validations;
  • Change controls;
  • Rejection and re-use of materials;
  • Complaints and recalls;
  • Contract manufacturers (including laboratories);
  • Agents, brokers, traders, distributors, repackers, and relabellers;
  • Specific guidance for APIs manufactured by cell culture/fermentation;
  • APIs for use in clinical trials

Forthcoming Q and A

In a concept paper published in October 2012; the ICH sought to have a Q and A document for ICH guideline Q7. These have been considered necessary in the wake of development of new quality concepts. It is being felt in Quality circles that new guidelines in respect of ICH guideline Q7 need to be issued or existing ones need to be updated to “harmonize expectations during inspections”.

One of the sections for which the ICH will consider Q and A documents relates to ICH guideline Q7.  The concept paper states that “…it has become apparent that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations which go beyond the intention of ICH Q7.” These will be taken up at conferences at various venues during May/June 2013.

References:

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm129098.pdf

http://www.gmp-compliance.org/enews_03408_ICH%20plans%20Q%26A%20on%20ICH%20Q7.html

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FDA guidance on method transfer

FDA guidance on method transfer is a kind of conundrum. On the one hand, there should be no complexity in analytical method transfer because the nature of method transfer is simple. On the other hand; there are no clearly defined guidelines on the subject from the FDA, making it something of a system that is free wheel in grand self-contradictory. The fact that the FDA is not the only regulatory body that has guidelines on method transfer adds to the lack of a straight jacketed approach to the topic.

So, what is FDA guidance on method transfer?

 Although there are no specified and clearly laid out guidance from the FDA on method transfer; these guidelines cover some forms of method transfer. They are based on the fact that analytical method transfer is the manner by which a laboratory becomes qualified to use a test procedure.

The pivot on which FDA guidance on method transfer revolves is that it is incumbent upon transferring and receiving laboratories to be compliant with set guidelines when they transfer or receive analytical methods. These guidelines in turn are governed by statistical and practical treatment of the resulting data.

Does the FDA have guidance on re validation?

Yes. FDA guidance on method transfer covers re-validation. Any receiving or transferring laboratory has to carry out re-validation of the method transfer in these circumstances:

  • When a method gets changed, and the new parameter is beyond the operating range
  • When there is a change or extension in the scope of the method
  • If a change of sample matrix/operating conditions contributed to the change of the scope of the method
  • If new instruments, meaning those whose characteristics were not covered by the initial validation are used in the validation
  • Where system suitability tests, or results of sample analysis, depart from preset acceptance criteria and when the source of this error cannot be traced to be fixed later

Reference:

http://www.nbchem.de/mediapool/120/1202675/data/110914_AMDVT_bn.pdf

 

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CMDR medical device classification

The Canadian Medical Device Regulations (CMDR) is the guidance that classifies medical devices in Canada.

Medical devices are classified according to the level of risk they pose for the user, be it the patient or the people employed in the healthcare industry. The global body that oversees this classification is The Global Harmonization Task Force (GHTF). This task force issues guidance documents that set out the risk classification of medical devices.

Risk categories according to the CMDR medical device classification

Accordingly, for the CMDR medical device classification, there are fourrisk categories of devices. These are Class I, ClassII, ClassIII, and ClassIV. CMDR medical device classification is a rule based system whose criteria are listed out in Schedule 1 of the CMDR.

Further, there are four classes of medical devices based on risk level: A, B, C and D. This rule based system is defined in this guidance document.

CMDR medical device classification: a summary

This is how the CMDR medical device classification can be explained in a nutshell:

  • Medical devices are classified into four classes (I, II, III, and IV) according to the CMDR medical device classification
  • Based on Schedule 1 Part 1, a rule based system; the manufacturer has to make this classification
  • The criterion for this classification is the controls placed on them. There are different licensing requirements depending on the class of the device, that have to be implemented for each of these classes
  • Under the CMDR medical device classification; there is no distinction between existing devices and new devices
  • For a Class I medical device that is being sold directly without a Canadian intermediary; a Medical Device Establishment Licenses (MDEL)is necessary
  • For all other classes of medical devices; the CMDR medical device classification requires implementation of ISO 13485:2003 quality system that is tailored to Canadian requirements.

References:

http://www.emergogroup.com/files/medical-device-regulatory-process-canada.pdf

http://www.ombuenterprises.com/LibraryPDFs/Medical_Device_Classification.pdf

http://www.globalcompliancepanel.com/control/w_product/~product_id=600289

 

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CMDR classification

The Global Harmonization Task Force (GHTF) is deemed with the task of issuing guidance documents on medical device risk classification. Its classification is made based on the risk level the medical device poses. The US, Canada and the EU are covered in the Task Force’s guidance.

The guidance that deals with medical device risk classification in Canada is the Canadian Medical Device Regulations (CMDR). The CMDR classification classifies devices into four risk categories (I, II, III, and IV). The basis for CMDR classification is a rule based system enunciated in Schedule 1 of the CMDR.

The CMDR classifies medical devices into four classes: A, B, C, and D, which are based on risk level. The guidance documentdefines thisrule based system.

A summary of CMDR classification

This is the essence of CMDR classification ofmedical devices:

  • CMDR classification classifies medical devices into four classes (I, II, III, and IV)
  • This classification has to be determined by themanufacturer in accordance with a rule basedapproach set out in Schedule 1 Part 1
  • The classification of these devices is determined by the controls placed upon them. These are implemented through different licensingrequirements, which vary according to the class of the device
  • Another outstanding feature of the CMDR classification is that it makes no distinction between “existing” devicesand “new” devices, i.e., the classification rules are the same irrespective of whether the medical device is being introduced for the first time into the market or has been around for a decade
  • A Medical Device Establishment Licenses (MDEL)is needed if a Class I medical device is being sold directly without a Canadian intermediary
  • CMDR classification requires all other classes of medical devices to implement SO 13485:2003 quality system to meet Canadian requirements.

References:

http://www.emergogroup.com/files/medical-device-regulatory-process-canada.pdf

http://www.ombuenterprises.com/LibraryPDFs/Medical_Device_Classification.pdf

http://www.globalcompliancepanel.com/control/w_product/~product_id=600289

 

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BRC risk assessment

BRC, short for British Retail Consortium, is a body that sets global safety standards for food. Its standards are part of a leading safety and quality certification program. With a membership of over 17,000 certified suppliers in more than 90 countries, BRC works through a coordinated network of over 80 accredited or recognized certification bodies.

Starts with top management

BRC risk assessment is aimed at improving processes and standardizing them across the globe. Risk management is a critical aspect of BRC standards. BRC risk assessment begins with the adaption of sound risk assessment principles percolating from the top management downwards.

Different types of assessments

BRC risk assessment seeks to make risk assessment the core of an organization’s function. It has clauses for the type of risk that has to be countered. The entire challenge of BRC risk assessment lies in the fact that it seeks to concretize subjective risk matters. Towards this end; it has no fewer than 27 assessments.

The sections of BRC risk assessment specify the kind of product and group that needs to be administered the specific risk assessment criterion. It also lists out legislative and safety requirements.

Guidelines for all stages of production

The important aspect of BRC risk assessment is that it has guidelines for every stage of production of food material, right from prior to production to post production. These are some of the important guidelines for BRC risk assessment:

  • The organization has to nominate a person for handling risk assessment;
  • The product’s risk assessment has to be verified from time to time;
  • The management system has to state the policy the organization is undertaking;
  • The organization has to adhere to stated documentation processes.

Put together with other important requirements; the BRC risk assessment is a tool to ensuring quality at every possible level.

Reference:

http://books.google.co.in/books?id=-bZdt9w9ycAC&pg=PA23&lpg=PA23&dq=brc+risk+assessment&source=bl&ots=GiWts9HBDd&sig=aqpqk8IHtYi635wAG1rIBBpUtkU&hl=en&sa=X&ei=NNZwUf2bBofmrAfH-4GICg&ved=0CEcQ6AEwAjgK#v=onepage&q=brc%20risk%20assessment&f=false

http://www.brcglobalstandards.com/Home.aspx

 

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BRC Risk Analysis

BRC risk analysis is about the guidelines issued by the international risk analysis body, the British Retail Consortium (BRC). Being a product of deliberations over a long period of time; BRC is today a global food safety standards body thatis hard onrisk analysis. This makes BRC risk analysisa unique proposition that stands apart from its US audit standards.

Tangibility has to be demonstrated

BRC risk analysis is considered so strong that today, risk analysis that satisfies the BRC core requirements is one of the important criteria manufacturing professionals around the world have to fulfill. Where it really stands out and towers heads and shoulders over other regulatory bodies is that it requires Risk Analysis to be tangible and demonstrable, rather than being something that is subjective. This is where the real challenge of meeting BRC risk analysis standards lies. This calls for knowledge of both the processes that go into risk analysis, as well as the guidelines required of lies.

Risk Analysis is the core area of difference

Of late, there has been a conscious effort to bridge the gap between US and BRC risk analysis standards. There are moves to harmonize each with the other. On the surface; since there are differences in the numbering of items; an impression may be gained that if one knows how to prepare one type of audit, it should be good enough for the other. This is not so, because although the criteria are more or less similar; it is in the area of risk analysis that the BRC risk analysis certification requirements are different.

The eventual aim of carrying out BRC risk analysis is that it equips organizations with the skills needed to develop compliant and relevant programs that help achieve quality systems objectives.

In arriving at a BRC Risk Analysis program; auditors have to be thorough with the following among other areas:

  • Areas of the operation in which risks exist
  • Sources of documentation
  • Classification of risks
  • Documenting current processes for mitigating risks
  • Proposing risk reduction strategies
  • Establishing timelines for process improvements
  • Following up on proposed process improvements
  • Application to regulatory and industry standards
  • Sources of documentation

Reference:

http://www.globalcompliancepanel.com/control/w_product/~product_id=600972

 

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Analytical method transfer

Analytical method transfer is an important element of a laboratory. A laboratory will be required to send or transfer its methods for a variety of reasons to another laboratory. During this process, analytical method transfer comes into play. Analytical method transfer has been described as“…the process of transferring a validated analytical method from a sending laboratory to a receiving laboratory, after demonstrating experimentally that it also masters the method”.

It follows from this definition that the analytical method transfer has to demonstrate at least three important components:

  • A study that is protocol-driven and has predetermined criteria for acceptance
  • Laboratories’ expertise in using and running a particular method has to be demonstrated
  • The method’s ability to fulfill its intended use must be verified.

Factors for the rise in use of transfer methods

Of late, there has been a discernible increase in the use of analytical method transfer. Some of the reasons for this phenomenon are an increase in outsourcing and subcontracting, which use methods like contract manufacturing and CRO’s. Added to this; there has been a general increase in the importance of bio pharmaceutical and biologic products of late, necessitating an increase in analytical method transfer. Because of this, the emphasis on good business practice and regulatory guidance has got reinforced.

How are analytical method transfer and validation related?

Analytical method transfer is closely intertwined with validation, for the simple reason that it is validated data that is transferred between laboratories. Unless data is verified; analytical method transfer is incomplete and unfruitful.

Difficulties involved in methods transfer between multiple laboratories

Challenges can arise when more than one company have to transfer data between multiple laboratories. This involves and requires having to use different approaches to transfer and validation. Also, the transfer is challenging and can become subjective, since the various laboratories involved in the transfer will have their own definitions and expectations of what is acceptable validation. Another important bottleneck in analytical method transfer is that different laboratories could use different facilities and instruments.

Reference:

http://www.nbchem.de/mediapool/120/1202675/data/110914_AMDVT_bn.pdf

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GlobalCompliancePanel
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Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539