Good Cleaning Validation Practices – 24th – 25th October 2011 Istanbul

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This cleaning validation training addresses cleaning validation from a life cycle perspective. There is more than one way to achieve a compliant cleaning validation program.

Destin A. Le Blanc provides insights related to understand the cleaning process in a specific situation so effective and efficient programs can be established and executed.

At the end of the course on Good Cleaning Validation Practices, participants should be able to understand and apply:

  • USA and European cleaning validation guidance documents
  • Importance of design/development for an effective program
  • Principles and calculations of residue limits for a wide variety of residue types, routes of administration, and dosage types
  • Selection of analytical methods, along with appropriate levels of analytical method validation
  • Selection of sampling methods and sampling sites, along with proper selection of blanks and controls
  • Appropriate strategies and documentation for sampling recovery studies
  • Cleaning validation master plan and/or policy components
  • Strategies to simplify validation protocols and validation implementation
  • Strategies for grouping to simplify validation
  • Appropriate documentation for cleaning validation protocols and reports
  • Monitoring, revalidation and validation maintenance for validated cleaning process

Who Should Attend

Professionals responsible for various aspects of cleaning validation including:

  • Validation scientists
  • Validation service personnel
  • Production engineers
  • Quality assurance specialists
  • Quality control technicians
  • Analytical chemists
  • Microbiologists
  • Regulatory affairs professionals
  • Pharmacologists
  • Toxicologists
  • Technical support scientists
  • Supervisors, managers and directors of groups supporting cleaning validation

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The Similarity Between Device Master Records & Chocolate Chip Cookies [Video]

The device design once complete, must be adequately transferred to manufacturing. This is typically accomplished through product specifications, standard operating procedures, work instructions and training.

Collection of Documents

Often a product specification is thought of as a document. The reality is the product specifications should be thought of as an association of written documents.

The product specifications typically include:

  • Assembly drawings
  • Component procurement specifications
  • Manufacturing instructions
  • Inspection
  • Test instructions
  • Digital data files
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  • Artwork associated with labels
  • Acceptance criteria
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Device Master Record (DMR)

The ultimate document to ensure adequate design transfer is the Device Master Record, or DMR.

The DMR is somewhat theoretical in that it is really a compilation of all the documents which are needed to realize the product.

For that reason, the DMR, is often established as an index which simply lists all of the documents needed to realize the product.

Contents of the DMR

The DMR typically includes the following documents:

  • Product specifications
  • Work instructions for device realization
  • Device history records/Forms to generate device history records
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Since these documents may be revising and changing and may be at various distribution points, the DMR typically is an index of all the documents.

Chocolate Chip Cookie Analogy

One very common analogy is to envision the DMR as a chocolate-chip cookie recipe. If the DMR is complete, by providing the DMR to someone they can make the exact same chocolate-chip cookies.

While this is somewhat simplified, it’s an excellent analogy, but in order to make the perfect chocolate-chip cookie we would want specifications for the grade of flour, chocolate chips, sugar and other components.

We’d also like to know which equipment was validated, how they are tested/inspected, what are the instructions for each processing step, etc.

If we have all the relevant information we can reproduce the cookies exactly.

The DMR is the key to any successful design transfer whether it is an internal transfer to manufacturing or a transfer to a Contract Manufacturing Organization (CMO).

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The process which will be described here is based on the process discussed in the MHRA’s guidance on Out of Specifications Investigation.

When an out of specification, atypical or suspect result is obtained, it is particularly important that all solutions and reagents associated with the test are retained, as this will greatly assist the investigation.

The MHRA advocate laboratory investigations should proceed in four phases as follows:

Phase I(a)

Phase I (a) consists of a preliminary review, by the analyst, to determine whether there has been a clear and obvious error or event that caused the OOS, atypical or suspect result.

Phase I(b)

Phase I (b) occurs after phase 1(a) has failed to identify a clear and obvious cause. This is a more detailed investigation by the analyst and supervisor to identify a laboratory assignable cause.

Phase II

Phase II occurs after the phase I investigation has failed to identify a laboratory assignable cause for the OOS, atypical or suspect result and are driven by written and approved instructions in order to test particular hypothesis.

Phase III

In Phase III all the information obtained during Phases I and II of the laboratory investigation, and any manufacturing investigation, is reviewed and assessed, and a decision is made on the disposition of the batch

Learn More About Laboratory Investigations

If you would like to learn more about laboratory investigations click here for an overview of this course.

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