Statistical Considerations for ICH Guidelines

Statistical Considerations for ICH Guidelines

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.

This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.

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Batch manufacturing record in pharmaceutical industry

A batch manufacturing record in pharmaceutical industry is information relating to the product and batch. It is a document that is intended to give a full and authoritative record of the manufacturing history of each batch of every product. The FDA defines a batch thus: “A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture”.

System of checkpoints

In the light of this definition, batch manufacturing record in pharmaceutical industry has to be understood as one that is basically based on the master formula record. It is created, checked, ratified and sanctioned by the designated, competent technical person/s that is responsible for the organization’s production and quality control.

In order to avoid wrongful reproduction, batch manufacturing record in pharmaceutical industry involves use of methods such as photo reproduction.

What should go into it?

A typical batch manufacturing record in pharmaceutical industry ideally consists of these details:

  • The product name
  • Its batch number
  • Date on which significant intermediate stage were commenced and completed
  • The name of  the person who is responsible for each stage of production
  • Initials of both operators who carried out significant processes and the persons who checked these
  • Details such as the quantity, batch number, quality control report number of each ingredient actually weighed, along with the amount of any recovered material that may have been added
  • Details of in-process controls, their results and signature of person who performed these
  • Whenever variation that exceeds expectation is observed, batch manufacturing record in pharmaceutical industry should make note of the theoretical yield and actual yield at every appropriate stage of production. These should be accompanied by an explanation
  • Details of authorization of any deviation, if any was made

References:

http://www.lifescienceleader.com/magazine/past-issues3/item/3502-is-the-reign-of-batch-processing-coming-to-an-end

http://malayinfo.blogspot.in/2012/07/issuance-of-batch-manufacturing-record.html

http://www.pharmatutor.org/articles/manufactuting-documentation-pharmaceutical-industry-development-implementation?page=0,1

 

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USP method transfer

USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012.

How is the new document different?

The US Pharmacopoeia had earlier issued the 1224 stimuli document in response to comments it received from users and professionals globally. The new version of chapter 1224, which is the general article, is different in one fundamental way in that it makes risk based assessment the criterion for the nature and scope of transfer activities. So, this new version of USP method transfer is different in one small, but very significant way.

What are the major elements of the new USP method transfer version?

The May 2012 USP method transfer recommends many new elements. Some of these are listed below:

  • The laboratories have to prepare a detailed analytical procedure with instructions that are sufficient and explicit enough to allow a trained analyst to perform it painlessly
  • All questions regarding the transfer process have to be clarified at a pre-transfer meeting between the transferring and the receiving units
  • The written analytical procedure and development validation reports have to be transferred to the receiving unit from the transferring unit
  • The transferring unit has to train staff of the receiving unit
  • A dry run of the procedure has to be conducted at the receiving unit
  • Issues that may need resolution have to be identified before the signing of the transfer protocol
  • All the required identification, calibration and qualification needed of respective analytical instruments have to be carried out
  • Compliance with relevant regulations of the laboratory systems of the two units has to be confirmed

What are the implications of failure to meet acceptance criteria?

According to the USP method transfer; failure of the sending or receiving fails to meet acceptance criteria qualifies as a serious, but not fatal error. It does not get classified under Out-of-Specification (OOS) result whose desired action is investigation into the root of the OOS. However, this requires discussion and justification of any deviation. Either of the laboratories –the sending or receiving –should investigate the reason for which the predicted acceptance criteria were not reached, and should take corrective measures. This process makes USP method transfer complete. The transfer can take place only when the acceptance criteria are met, the failure of which prevents the transfer from taking place.

Reference:

http://www.drugregulations.org/2012/05/new-usp-requirement-for-analytical.html

 

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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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Phone:800-447-9407
Fax:302-288-6884
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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

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539