USP 1058 analytical instrument qualification

USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for its intended use and application. While system suitability and method validation activities have specific guidelines and procedures; analytical instrument qualification is not so specific. There are conflicting opinions and viewpoints regarding USP 1058 analytical instrument qualification.

Though subjective, analytical instrument qualification is central

Analytical Instrument Qualification (AIQ) stands at the base of the components that go into data quality; the other three components being Analytical Method Validation, System Suitability Tests and Quality Control Check Samples. Why is this so? This is because a sound AIQ lies at the root of the ability of an instrument to meet its intended application. AIQ is not a standalone event in the analytical instrument qualification process. It consists of many related activities.

The four phases of AIQ

USP 1058 analytical instrument qualification requires activities to be grouped into four phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).In brief, these are what these phases are:

Design Qualification

According to USP 1058 analytical instrument qualification; a DQ is the documented set of activities that lay out the functional and operational specifications of the instrument. It also mentions the criteria for selection of the vendor, based on the intended purpose of the instrument. The DQ can be performed by both the manufacturer and the user.

Installation Qualification

IQmay be described as the documented collection of activities that are necessary to establish that an instrument is a) delivered as designed and specified; b) it is properly installed in the selected environment, and c) this is done in an environment that is suitable for the instrument. Whether an instrument is new or was pre-owned, or exists on site but has not been previously qualified; IQ is required.

Operational Qualification

OQ testing follows IQ. It concerns the operational part of AIQ. It is the documented set of activities with which to demonstrate the ability of an instrument to function according to its operational specification in the selected environment.

Performance Qualification

PQ is the last stage of USP 1058 analytical instrument qualification. PQ is the documented collection of activities that is necessary to show that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use.

References:

http://www.drugfuture.com/Pharmacopoeia/USP32/pub/data/v32270/usp32nf27s0_c1058.html

 

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Sterilization

In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation.

Sterilization is part of inspections

Sterilization is essentially linked to inspectional objectives. The FDA states the following:  “for sterilization processes, the primary device specification is the desired Sterility Assurance Level (SAL). Other specifications may include sterilant residues and endotoxin levels.”

Important processes labs have to comply with

The FDA has a detailed set of processes that laboratories have to comply with. These are some of the more important ones:

  • The laboratory has to confirm that the sterilization process was validated after the validation study was reviewed
  • It has to review and verify the specific procedure or procedures for the said sterilization process, as well as for the methods that were used to control and monitor the process
  • If during the review of the Device History Records (which include process control and monitoring records, acceptance activity records, etc.) it is discovered that the sterilization process falls beyond the organization’s stated threshold for operating or performance parameters, the company has to do these:

–        It has to determine whether anynonconformance was taken care of in the prescribed manner; and

–        Once this is done, it has to review the equipment adjustment, calibration and maintenance

  • If the laboratory has a system in which the sterilization process is software controlled, it has to confirm that the software was validated
  • The company has to ensure that only appropriately qualified and trained personnel have to implement the sterilization process

Reference:

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170829.htm

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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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