ISO 13485 purchasing procedure

ISO 13485 has purchasing procedures for suppliers. ISO 13485 purchasing procedure is listed in Section 7.4 and its sub sections. The outstanding feature of this section is that the ISO is not clear about the expected levels of control a supplier has to have in place. It simply states that a documented procedure is required for purchasing and that the purchased products have to be compliant with specified requirements. This leaves scope for a lot of ambiguity and subjectivity in the ISO 13485 purchasing procedure.

The details of ISO 13485 purchasing procedure are spelt out in sections 7.4.1 and 7.4.2. It is important to know what these sections require. As stated; in being unclear, this section leaves a lot of judgmental application, because given the nature of products that suppliers are required to supply; there is scope for interpretation.

Section 7.4.1

“The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained”.

ISO 13485 purchasing procedure is based on the buyer’s requirement. It is the organization that has to decide and set the criteria for selection, evaluation and re-evaluation. This is entirely open and dependent on the particular need. The core areas are prone to be open to personal and individual, organization-based needs. It could source its requirements from its selected supplier. This search for the supplier could be based on advertisements or word of mouth or through any source the buyer is comfortable with. Evaluation and revaluation also carry the same interpretative nature, since there are no rigid criteria by which they can be set.

Section 7.4.2

Section 7.4.2 is the next important part of ISO 13485 purchasing procedure. It states the following:

“Purchasing information shall describe the product to be purchased, including where appropriate requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system.The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.”

Here too, there is no clear explanation of what kind of customer requirements have to be taken into consideration by the supplier. There is mention only of broad requirements, but not of the smaller, less visible points, such as what has to go into the products or packaging.

Given this haziness; ISO 13485 purchasing procedure has turned out to be a procedure that is open to debate. The Global Harmonization Task Force (GHTF) is in the process of making the purchasing procedure and supplier control tighter.

Reference:

http://www.nqa-usa.com/resources/articles_detail?id=43

 

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ISO 13485 design and development

ISO 13485 is the blueprint for quality management in medical devices. Design and development being very critical components of a medical device; ISO 13485 design and development is considered a very important section relating to this aspect of a medical device. Being the extant standard; the ISO 13485 standard has superseded a number of previous standards.

How important is ISO 13485 certification?

It is important for organizations to become ISO 13485 certified, because although this certification is not an end in itself in that it does not mean that the requirements of 9001 are being fulfilled or that the organization is automatically certified as having the ability to meet the standards set in any country; it means that the organization’s management system is being aligned to the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements globally.

What does ISO 13485 design and development entail?

ISO 13485 design and development is all about ensuring medical devices’ compliance with prescribed standards of global regulators.

Risk management is central to ISO 13485 design and development

Risk management is at the core of the quality management system, and has to be built into a product at the design and development stage. Built into the design and development stage; it has to permeate the product throughout its life cycle. Many organizations do not realize this, with the result that they end up messing up their certification. They think that risk management is good or necessary only at the design and development stage, which is actually not so.

Ensuring conformity without design and development controls

Another important element of ISO 13485 design and development is that of conformity. The way in which conformity is related to ISO 13485 design and development is that conformity with ISO 13485 has to be demonstrated when the product is free from design and development controls. When the product shows conformity even sans design and development controls; it is a sure means of ensuring that it meets ISO 13485 design and development standards.

References:

http://www.qualitymag.com/articles/85096-understanding-iso-13485

http://www.qualitydigest.com/magazine/2008/sep/article/iso-13485-just-facts-please.html#

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ISO 13485 customer property

ISO 13485 2003 is the global standard that concerns itself with quality management for medical devices.

ISO 13485 has a section on how businesses should deal with customer property. ISO 13485 customer property is covered in ISO 13485: 2003 Section 7.5.4. The aim of ISO 13485 customer propertyis to ensure that the property a customer leaves with an organization, which can range from intellectual property or confidential health information, is kept intact. The organization has to exercise utmost care with customer property during the time it is under the organization’s control or being used by the organization.

Sets out reporting rules

It is the duty of the organization to identify, verify, protect and safeguard customer property that comes into its custody. If the actions of an organization results in any loss or damage of customer property or make it unsuitable for use, the organization has to report this to the customer and maintain records of the same.

Extension in the next section

The regulation on customer protection ensured in ISO 13485 customer property finds reinforcement in Section 7.5.5. This section prescribes regulation on how to preserve customer property. This is the essence of this section:

According to this second provision on ISO 13485 customer property; the organization in whose care a customer property has been placed has to not only ensure its upkeep; it should also make sure the conformity of product during the time it is with the organization is kept intact. This has to be maintained till the property reaches its intended destination.The elements included under preservation are identification, handling, packaging, storage and protection.Preservation has to be for the whole product as well as its constituent parts.

Once an organization accepts a customer property; it has to establish documented procedures or documented work instructions for preserving the conformity.

These have to be consistent with the storage conditions of the product unique to it.

Deemed as control of records

The clauses relating to ISO 13485 customer property are bunched under control of records. So, any item covered under ISO 13485 customer property is treated as a record. Accordingly, these customer properties have to be preserved for a period equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by regulatory requirements.

References:

https://trello.com/card/iso-13485-2003-section-7-5-4-customer-property/5065bb306a04abb303aad139/64

http://www.praxiom.com/iso-13485-standard.htm

http://sic.com.ua/wp-content/uploads/2009/11/iso-13485-2003.pdf

 

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ICH Q7 guidelines

What is ICH Q7?

The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.

When did it come into effect?

The ICH Q7 was arrived at by the International Conference of Harmonization (ICH), which is why it gets its name. Adapted in November 2000, it came into being after three of the world’s leading medical device markets, namely the EU, Japan and the US agreed to it.

Important sections for day-to-day implementation

Although a comprehensive guideline that covers almost all aspects of GMP for API in its 19 section; a few sections are more important than the rest. It makes sense to be aware of these sections and implement them for day-to-day use.

  1. Introduction and glossary: Most people only glance at this section and its sub-sections, but it contains very important details. For instance, it contains unique definitions, especially those on API starting materials and manufacturing. Unique definitions by experts are carried here. They help to properly apply the intent of ICH Q7.
  2. Buildings and facilities: Extremely important because it contains reference to minimum quality of potable water, closed systems and contact utilities.
  3. Process equipment and cleaning: This states that contact surfaces of all materials should not be able to alter the quality of the product or the material beyond stated or established requirements.
  4. Production and inprocess controls: This section is vital because it states that deviations need to be documented under API GMP.
  5. Process Validation: Undoubtedly the most critical section of GMP, because this is what qualifies and validates a process. It also carries important issues such as qualification vs. validation.
  6. Rejection and reuse of materials: ICH Q7 is perhaps the only document that precisely defines these terms. But for this, there would be considerable confusion about what we would be doing under API GMP.
  7. Agents: Outcome of the Haitian situation in the mid-1990’s, where children died from glycerube contamination; this requires maintenance and traceability of records and processes from manufacturer to user.

 

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ICH guidelines for API

ICH guidelines for API are guidelines from the ICH specific to the active pharmaceutical ingredient (API) of the drug. A small note about ICH Q7:

The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). The scope of this guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.

When did it come into effect?

The International Conference of Harmonization (ICH), which was adapted in November 2000, formulated the ICH Q7.  After concurrence from three of the world’s leading medical device markets, namely the EU, Japan and the US; this instrument was executed.

ICH guidelines for API

ICH guidelines for API come under a section of the ICH Q7 that is devoted to this aspect of a drug. ICH guidelines for API relate to these important aspects of a drug’s API:

Stress testing: whenever available, data published in scientific publications aimed at supporting the identified degradation products and pathways should be provided. If these data are not available; stress testing has to be carried out.

Selection of batches:normally, data from stability studies on at least three primary batches of the API should be provided. For those existing active substances that are known to be stable; data from two primary batches are sufficient.

Container closure system: ICH guidelines for API state that the stability studies should be conducted on the API packaged in a container closure system that is similar to, or ape, the packaging proposed for storage and distribution.

Specification: in these studies, testing of those attributes of the API that are susceptible to change during storage and could influence quality, safety and/or efficacy should be included.

Testing frequency: ICH guidelines for API state thatthe frequency of testing should be sufficient to establish the stability profile of the API for long-term studies.

Storage conditions: an API should be evaluated under storage conditions (with relevant and necessary tolerances) that test its thermal stability and, if applicable, its 91 sensitivity to moisture. Here, it is stated that both the storage conditions and the lengths of studies chosen should be enough to cover storage and shipment.

ICH guidelines for API for Active pharmaceutical ingredients intended for storage below -20°C

The ICH has guidelines for API that is intended for storage below -20°C.

These are:

Stability commitment

Evaluation

Statements and labelling

On-going stability studies

Reference:

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1F/Stability_Guideline_WHO.pdf

 

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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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