Q7 guidelines

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API).

Q7 guidelines are very comprehensive

More than 12 years after they were mooted in November 2000; Q7 guidelines continue to be the driving force for API GMP regulations around the world. These relate a large number of areas concerning API, some of which are:

  • Quality management, which covers principles, responsibilities of the Quality Unit(s), internal audits, product quality review and others;
  • Personnel, which takes into account personnel qualifications, hygiene and so on;
  • Qualifications of Consultants;
  • Building and facilities;
  • Process equipment;
  • Documentation and records;
  • Materials management;
  • Packaging and labeling, and so on.

Need for change

Despite the good intention and comprehensiveness of these guidelines; in October 2012, the ICH Working Group issued a concept paper on the working of these guidelines. The areas of concern were about harmonization as well as some ambiguities that had crept in into the working of this guideline.

The essence of the Working Group’s observations was summed up thus: “It has become apparent, based on the approval and implementation of ICH Q8, Q9, Q10, Q11 principles into GMP of APIs that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations beyond the intention of ICH Q 7”.

Many areas need reform

According to the committee, many Q7 guidelines had issues that needed to be addressed and requiring review. These include supply chain control, outsource management, monitoring of impurity profiles, quality systems, the application of the guidance to biological medicines and biotechnology products, Q7’s relationship to the Q5D Guideline on the Quality of Biotechnological Products, and expectations for manufacturing done specifically for clinical trials.

More corrective action needed

It has said at the time of the release of this report that it will suggest changes to these Q7 guidelinesafter a new working group, formed for the purpose of assessing and recommending changes, will offer its advice on suggested issues.

References:

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

http://www.raps.org/focus-online/news/news-article-view/article/2520/ich-working-group-calls-for-revisions-to-q7-guideline.aspx

 

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Method transfer FDA

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to ensure that validated method transfer is carried out.

For a lab to meet method transfer FDA has set; it has to ensure that some pre-method transfer steps are adhered to. These include:

  • Unambiguous and clear communication between the sending and receiving lab on all the aspects of method transfer
  • Nomination of ideally a single person or point of contact between the sending and receiving labs, a person who will coordinate on the details of the transfer
  • Complete and clear assessment of the method of transfer
  • Identification of the required method transfer
  • Evaluation of issues arising out of the context of the location, such as data collection systems, instruments and reagents and coagulants.

Documents to be sent by the sending laboratory

To meet method transfer for FDA requirements, the pre-approved transfer protocol of the sending laboratory will typically consist of the following documents:

  • General transfer process
  • Definition of responsibilities of both parties
  • Specifics of the acceptance data
  • A list of the methods
  • Categorization of the methods
  • A description of samples and materials
  • Description of batch and lot records
  • Definition of parameters and instrumentations

Materials to be sent by the sending laboratory

Talking about the materials to be provided by the sending laboratory, these are usually part of method transfer the FDA requires:

  • Method, which consists of system suitability parameters, rationale for chosen, parameters, step-by-step directions and safety considerations
  • Validation report
  • Reference standards
  • Samples for evaluation, and
  • Supplies that are difficult to procure

Reference:

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

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Master Production Record (MPR)

A Master Production Record (MPR)is one of the several important documents that a manufacturer of finished pharmaceuticals has to maintain and furnish. It is one of the indispensable parts of pharmaceutical good manufacturing practices (GMP’s). FDA’s regulations on Master Production Record (MPR) are found in Code of Federal Regulations (CFR)’s Title 21, Volume 4. The current standard was revised on April 1, 2012.

Emphasis on double checking

FDA’s Master Production Record (MPR) guidelines are framed with the intention of ensuring that the finished pharmaceutical products maintain the same uniformity across each batch, no matter how many batches are produced of the pharmaceutical product. The manufacturer has to maintain records for each batch and stage of production. These batches have to be prepared, checked and signed by one person designated by the organization. Another independent, second person has to cross check these and carry out the same procedures, namely prepare, check and sign of the first person.

What should the Master Production Record (MPR) contain?

The FDA has clear guidelines on what all should go into the Master Production Record (MPR). It should have these:

  • The product’s name and strength as well as a description of the dosage form
  • The name, weight and measure of each active ingredient
  • Full list of the components that have gone into the drug
  • Aprecisedescription of the weight or measure of each component using the same weight systemfor each component
  • A Master Production Record (MPR) should also have a statement about the excess quantity of any of its components
  • It should also have a statement of theoretical weight or measure that the drug had at different, designated phases of processing
  • A description of the drug product containers
  • The Master Production Record (MPR) should have allspecifications,sampling and testing procedures,manufacturing and control instructions, precautions to be followed and special notations.

Reference:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.186

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ISO 13485 statistical techniques procedure

Being the global standard for quality management systems in medical devices; ISO 13485 has many controls and checks built in at various stages of the product design and development. One of these is the ISO 13485 statistical techniques procedure. This is a means to ensuring that product characteristics and process capability are measured and checked in a statistical manner to ensure their conformity with the relevant global standards.

Processes are at the core of statistical techniques

ISO 13485 statistical techniques procedure is all about matters like processes, process approach, how processes can be improved, and how effective and efficient a process is. We can understand ISO 13485 statistical techniques procedure as statistical methodologies that can be used as the basis for a whole lot of quality procedures such as sampling plan(s), quality assurance, failure analysis, and general data analysis.

All procedures are important and have to be statistical

The important point ISO 13485 statistical techniques procedure is that this has to be incorporated into the entire chain of quality procedures, as we just saw. For example, in situations where sampling is to be carried out for the purpose of establishing product characteristics and process capability, the sampling has to be based on established statistical methodologies.

The same goes for other procedures such as quality assurance, failure analysis, and general data analysis. In carrying out each of these; the quality personnel have to base their work on established statistical methodologies.

References:

http://www.gpacmfg.com/ISO_13485_Statistical.html

http://www.lne-america.com/quality-news-faqs/progress-report-news/iso-13485-works-for-fda.html

http://elsmar.com/Forums/showthread.php?t=9966

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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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