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Validation of People-Dependent Processes

This document outlines the validation process for people-dependent packaging processes. It stresses the importance of: 1) Eliminating controllable sources of variation through standardized equipment, materials, components, and procedures. 2) Developing detailed written operating procedures and training personnel on qualification. 3) Continuously monitoring the process for drift once the packaging procedure has been validated, and retraining personnel if needed.

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Angel Cvetanov
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295 views

Validation of People-Dependent Processes

This document outlines the validation process for people-dependent packaging processes. It stresses the importance of: 1) Eliminating controllable sources of variation through standardized equipment, materials, components, and procedures. 2) Developing detailed written operating procedures and training personnel on qualification. 3) Continuously monitoring the process for drift once the packaging procedure has been validated, and retraining personnel if needed.

Uploaded by

Angel Cvetanov
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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VALIDATION OF PEOPLE-DEPENDENT PROCESSES

In the validation of people-dependent packaging processes, a key element is the


elimination of controllable sources of variation. All equipment, materials, and
components should be prequalified for the packaging operation. Where possible, the
use of fixtures, holders, and special equipment should be implemented to reduce
variation. Operating procedures should be developed, and the packaging operation
should be outlined using written descriptions, illustrations, photographs, and
samples. An important part of these procedures is operator training and qualification.
Typically, training and qualification can be accomplished by a combination of
observation of conformance to procedure, formal and informal testing, and inspection
and testing of the packaged product. To evaluate the system, the manufacturing
procedure should be challenged by having people unfamiliar with procedure perform
it; if they have difficulty, the procedure should be refined and retested. Acceptance
criteria (e.g., the maximum number of defects) must be identified.
Once satisfied that the packaging procedure is appropriate, a minimum of three
consecutive lots, batches, or runs without direct observation is recommended to
confirm that the process consistently produces a product that meets specifications.
In general, people-dependent processes typically require more than three runs. The
package should be thoroughly inspected or tested to determine conformance to
specifications and the number of defects. The process performance must also be
continuously monitored to detect drift. Operators will periodically require retraining
and should definitely be retrained when drift is detected. Any process changes must
be assessed as to the impact on the operator's ability to perform.

(a) Adequate facilities, trained personnel and approved procedures must be available for sampling,
inspecting and testing starting materials, packaging materials, and intermediate, bulk and finished
products, and where appropriate for monitoring environmental conditions for GMP purposes.

(b) Samples of starting materials, packaging materials, intermediate products, bulk products and
finished products must be taken by methods and personnel approved of by the quality control
department.

(c) Test methods must be validated.

(d) Records must be made (manually and/or by recording instruments) demonstrating that all the
required sampling, inspecting and testing procedures have actually been carried out and that any
deviations have been fully recorded and investigated.

(e) The finished products must contain ingredients complying with the qualitative and quantitative
composition of the product described in the marketing authorization; the ingredients must be of the
required purity, in their proper container, and correctly labelled.

(f) Records must be made of the results of inspecting and testing materials and intermediate, bulk
and finished products against specifications; product assessment must include a review and
evaluation of the relevant production documentation and an assessment of deviations from
specified procedures.
 Make sure equipment qualifications have been completed or are at least in the
validation plan to be completed prior to executing the ATMV.

(2) Examples of equipment settings to be captured in the test method documentation


include environmental or ambient conditions, magnification level on microscopes,
lighting and feed rate on automatic inspection systems, pressure on a vacuum decay
test and lighting standards in a cleanroom, which might involve taking lux readings in
the room to characterize the light level.

(3) Work with training personnel to create pictures of the defects. It may be beneficial
to also include pictures of good product and less extreme examples of the defect,
since the spectrum of examples will provide better resolution for decision making.

(4) Where possible, the visual design standards should be shown at the same
magnification level as will be used during inspection.

(5) Make sure that the ATMV is run using the most recent visual design standards
and that they are good representations of the potential defects.

4.2.6.2 Step 2 – Establish acceptance criteria: 

(1) Identify which defects need to be included in the test.

Kvalifikuvana soba so svetlosen intenzitet vo luksi

Kvalifikuvani I kalibrirani vagi

Kvalifikuvan pribor – cist

Kvalifikuvan material za pakuvanje- test na izdrzlivost, test na inertnost so cvetot, child proof,
dimenzii, uzorciran, proveren, cist

Kvalifikuvan personal so trening - sop za pakuvanje

Zastitna obleka- RAKAVICI, maska, kapa

Worst case scenario

Podgotovka na potrebni materijali za pakuvanje

Kalibriranje na vagata

Podgtovka na cist pribor

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