IIN311-B - Case Study and Reading Control Form - Case 2 - 1069349

Case study and reading control form
Documentation template & evaluation instrument

Document ID : IIN311-B Effective Date: 13-AUG-2019 Rev : 2
Case: 483’s related to failed administration Process Validation Page: 1 of 7
program
Table of Contents
1. Case / Reading title: ................................................................................................................................... 2
2. Case Study / Reading Overview ................................................................................................................ 2
3. Case questions ........................................................................................................................................... 3
4. Student analysis reflection & take away .................................................................................................. 4
5. References used by the student ............................................................................................................... 5
6. Evaluation Results ...................................................................................................................................... 7
7. Evaluation Rubric ....................................................................................................................................... 7
IIN311-B - Case study and reading control form
This document is licensed as Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0), according to creative commons. See further information regarding licensing on the following link
https://creativecommons.org/licenses/by-nc-sa/4.0/deed.en
IIN311-B Rev: 2 Case study and reading control form Page: 2 of 7
1. Case / Reading title:

Unit # and name: 1 - Administración de un programa/plan maestro de validaciones
Title: Case: 483’s related to failed administration Process Validation program
Value: 5 points
Target number of words: 250 ±50 words
Last day to send: As shown on the email.
Send to: cesar.tejeda@intec.edu.do
2. Case Study / Reading Overview

The FDA
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of
Health and Human Services, one of the United States federal executive departments. The FDA is responsible
for protecting and promoting public health through the control and supervision of food safety, tobacco products,
dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines,
biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED),
cosmetics, animal foods & feed and veterinary products.
FDA Inspection
The FDA inspector begins an inspection by presenting credentials and the original signed FDA-482 form, Notice
of Inspection, to the most responsible person at the firm that will be inspected, usually the management
representative (like Quality Manager).
The FDA and inspectors request a tour of the facility and ask questions to confirm and evaluate that resources,
personnel, and the overall facility are appropriate. During the tour, they request procedures and other
documents, including critical process validation elements such as Validation Master Plan (VMP), Validation
Plans (VP) and Validation protocols.
Prior to departing the company, the FDA inspectors are required to provide the inspection site an FDA-483. The
FDA-483 is a List of Objectionable Conditions, in writing, if any significant objectionable observations relating to
products and/ or processes or other violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Medical
Device Regulation Act and as well as other Acts were found during the inspection. The FDA will only list
observations, which are significant and relative to regulated products or processes.
FDA Logo
This PPT is licensed as Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0), according to creative commons. See further information regarding licensing on the following link
The Warning Letter (FDA-483)

An FDA Warning letter or 483 contents:
– Significant objectionable conditions or practices.
– Objectionable conditions or practices listed in descending order of significance.
– Recurring/repeat observations may be explicitly noted.
Things that are not contained within a 483:

– Content of labels and labeling.
– Promotional materials.
– Establishment registration.
The context
Three (3) warning letters are part for this case study. Each of a different company:
Table 1 - List of companies and warning letters within the scope of this Case Study
Company Company overview FDA Warning Letter

Fisioline Fisioline is an Italian manufacturer of electro-medical https://wayback.archive-
equipment, founded in 1985. Fisioline manufactures laser it.org/7993/2019020811
devices. In 2004, Fisioline’s laser devices obtained the FDA 4246/https://www.fda.go
approval in the USA. v/ICECI/EnforcementAct
ions/WarningLetters/201
3/ucm344747.htm
AG Industries AG Industries started in 1982. As AG began to grow, their https://www.fda.gov/ICE
specialty became the respiratory equipment and the supplies CI/EnforcementActions/
for those systems. As respiratory products became the center WarningLetters/ucm451
of AG, they recognized the constant demand of the systems for 494.htm
disposable supplies. Along with growing manufacturing
capabilities, AG’s innovation grew to include HEPA & custom
filters, product design, and a larger focus on fluid filtration
including gasses and liquids. Over 30 years AG has grown to
into a vertically integrated company with more than 65 full time
employees and a worldwide presence.
Ropack, Inc. Ropack Inc. produces and distributes pharmaceutical products. https://www.fda.gov/ICE
The Company offers drugs research and development, CI/EnforcementActions/
analysis, manufacturing, packaging, and distribution services. WarningLetters/2016/uc
Ropack conducts its business in the United States and Canada. m538424.htm
3. Case questions
1. Click and read carefully the three warning letters shown above. And answer the following
1.1. What critical elements of the validation program were missing or found not conforming for each
of the companies?
1.2. Make a list of the section(s) of the CFR, related to process validation, which were found as not
conforming (example 21 CFR 820.75(a))?
1.3. From your point of view, what remediation plan would you recommend to the company to do in
order to answer the FDA? (Hint: Remember the validation lifecycle approach and the order of
critical elements: Validation Master Plan (VMP), Validation Plans (VP) and Protocols)
4. Student analysis reflection & take away

Student name: Esteban Luciano
Group number (if applies): N/A
Company Answers
Fisioline Question 1.1: In the FDA Warning Letter for Fisioline, the investigator described
nonconformities under the Code of Federal Regulations (CFR). The nonconformities
related to the firm’s validation program are the following:
1. Failure to validate their computer software for its intended use.
2. Software validation documentation for a new user interface did not include
protocols with acceptance criteria prior to validation, and requirements which
ensures the results of design validation are documented.
3. Verification procedures did not include protocols with acceptance criteria.
4. Failure to establish and maintain procedures to ensure that formal documented
reviews of the design results are planned and conducted at appropriate stages of
the device’s design development.
5. Some procedures did not include documentation of nonconforming products, nor
include the reworked product in the Device History Record (DHR).
6. The calibration timeframes for primary measuring equipment devices were not
specified in the calibration procedures.
7. Incorrect identification of the primary measuring equipment on the calibration
certificates.
8. The measuring equipment used during in-process and finished device testing were
not identified in the acceptance records.
Question 1.2: The sections that were found not conforming in the FDA Warning Letter for
Fisioline are:
1. 21 CFR 820.70(i), validation for automated processes.
2. 21 CFR 820.30(g), for design validation.
3. 21 CFR 820.30(f), for design verification.
4. 21 CFR 820.30(e), design review.
5. 21 CFR 820.90(b)(1), nonconformity review and disposition.
6. 21 CFR 820.72(a), control of inspection, measuring, and test equipment.
7. 21 CFR 820.72(b)(2), calibration records.
8. 21 CFR 820.80(e), acceptance records.
Question 1.3: I would recommend the firm to create a validation plan in order to comply
with the nonconformities found by the FDA investigator. Also, I would suggest the VRB to
review the Validation Master Plan to investigate the reasons for that nonconformities and
document it to make sure it does not happen again.
AG Industries Question 1.1: In the FDA Warning Letter for AG Industries, the investigators described
some serious deviations under the Code Federal Regulations (CFR). The firm presented
nonconformities in the validation program:
1. Failed to adequately validate a process which cannot be fully verified by
subsequent inspection and testing in various pieces of equipment.
2. Failed to present a validation plan for the allowable regrind percentage for the
plastic scrap material.
3. Failed to address accepting failed validation data for the flange thickness of the
filter by changing the specifications and tolerances so that all product produced
was acceptable.
4. Failed to adequately establish procedures for finished device acceptance, where
only medical device product quality inspections were conducted.
5. Failed to adequately establish procedures for acceptance of incoming product,
where not enough specifications were presented in the Device Master Record
(DMR).
6. Failed to establish procedures that define the responsibility for review and
authority for the disposition of non-conforming product, where there are no Non-
Conformance Reports (NCR).
7. Failed to establish procedures to ensure equipment is routinely calibrated,
inspected, checked, and maintained; where maintenance logs did not include
calibration activities or instrumentation inspection.

Question 1.2: The sections that were found not conforming in the FDA Warning Letter for
AG Industries are:
1. 21 CFR 820.75(a), for process validation.
2. 21 CFR 820.80(d), final acceptance activities.
3. 21 CFR 820.80(b), receiving acceptance activities.
4. 21 CFR 820.90(b)(1), nonconformity review and disposition.
Question 1.3: I would recommend AG Industries to settle validation commitments and a
new validation plan to assess these violations of the CFR. Also, execute Non-
Conformance Reports procedures, and establish procedures for finished device
acceptance and acceptance of incoming product. Make sure the procedures implemented
on the new validation plan are documented and filed in the firm’s VMP.
Ropack, Inc. Question 1.1: In the FDA Warning Letter for Fisioline, the investigator described
nonconformities under the Code of Federal Regulations (CFR). The nonconformities
related to the firm’s validation program are the following:
1. Failed to ensure process validation of a manufacturing process.
2. Failed to present a validation summary report as required by the VMP.
3. Failed to establish and maintain procedures for changes to a specification,
method, process, or procedure; where a product’s batch size without verification
or validation.
4. Failed to establish and maintain adequate procedures for implementing corrective
and preventive action, where the current one lacked several requirements.
5. Failed to establish and maintain adequate procedures to control non-conforming
products.
6. Failed to validate computer software for its intended use.
7. Failed to establish and maintain adequate procedures to ensure that equipment is
routinely calibrated, inspected, checked, and maintained.
8. Failed to ensure that all inspection, measuring, and test equipment is suitable for
its intended purposes.
9. Failed to establish and maintain adequate calibration procedures.
10. Failed to establish and maintain adequate procedures to control all documents.
Question 1.2:
1. 21 CFR 820.75(a), process validation.
2. 21 CFR 820.70(b), production and process changes.
3. 21 CFR 820.100(a), implementation of CAPA.
4. 21 CFR 820.90(a), control of nonconforming product.
5. 21 CFR 820.70(i), validation for automated processes.
7. 21 CFR 820.72(b), calibration procedures.
8. 21 CFR 820.40, document controls.
Question 1.3: I would recommend Ropack, Inc., in order to comply with the FDA Warning
Letter, to review the validation plans made for manufacturing processes, considering
computers’ software, equipment maintenance, and calibration procedures. Also, review
the validation plans for CAPA procedures, validation summaries, and adequate
procedures to control non-conforming products. I would also suggest to the VRB to update
the VMP according to the nonconformities made by the FDA investigators.
5. References used by the student
In this section, the student includes external sources of information e.g. standards, regulations, upon which the
procedure/guidance is based or to other related procedures and relevant documents. APA format must be used.
ID Title
1 Electronic Code of Federal Regulations (2020). Part 820 – Quality System Regulation. Retrieved from:
https://ecfr.gov/cgi-bin/text-
idx?SID=1de55052c06b011bbfcfe2d28ca99069&mc=true&node=pt21.8.820&rgn=div5#_top
2
3
(add or remove rows of the table as required)
6. Evaluation Results
Completion Accuracy Comprehension Organization Conventions Final score
(Average)
7. Evaluation Rubric
Each case study / reading will be 5 valuated in points each. The 5-point score will be an average of the 5
different categories shown below:
Score Completion Accuracy Comprehension Organization Conventions
5 The answer is complete. All information provided Content demonstrates a Content is well- No major grammatical or
is accurate. deep understanding of, organized and easy to spelling errors. No more
and engagement with, read. Points follow a than two minor errors.
the text(s). logical progression.
4 The answer is missing All information provided Content demonstrates Content is well- No major grammatical or
slight details is accurate. Some understanding of, and organized and easy to spelling errors. No more
improvements can be engagement with, the read. Points follow a than five minor errors.
made text(s), logical progression.
Minimal changes can do
the organization better.
3 The answer is missing Most information Content demonstrates Content is organized and Some major and minor
multiple details. provided is accurate. basic understanding of easy to read. Points errors that don’t
the text(s). follow a mostly logical necessarily impair
progression. communication.
2 Content suggests lack of Some information Content demonstrates Content may be Major and minor errors
preparation or provided is accurate. less than basic unorganized and difficult significantly weaken
comprehension. understanding of the to read. Points do not quality of
text(s). follow a solidly logical communication, although
progression. still comprehensible.
1 Content only marginally A small amount of the Content demonstrates a Content is unorganized, Communication seriously
related to the information is accurate. lack of understanding of illogical, and difficult to impaired by multitude of
question/prompt. the text(s). read. spelling/grammatical
errors.
0 Content fails to meet the None of the information Content demonstrates a Content is very poorly Multitude of major and
basic requirements of provided is accurate. complete lack of organized, illogical, and minor errors make
the task. understanding of the difficult to read. answer
text(s). incomprehensible.
End of the document


IIN311-B - Case Study and Reading Control Form - Case 2 - 1069349

Caricato da

Informazioni sul documento

Titolo originale

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

IIN311-B - Case Study and Reading Control Form - Case 2 - 1069349

Caricato da

Copyright:

Formati disponibili

Case study and reading control form

Documentation template & evaluation instrument

1. Case / Reading title:

2. Case Study / Reading Overview

The Warning Letter (FDA-483)

Things that are not contained within a 483:

Company Company overview FDA Warning Letter

4. Student analysis reflection & take away

calibration activities or instrumentation inspection.

the VMP according to the nonconformities made by the FDA investigators.

5. References used by the student

Score Completion Accuracy Comprehension Organization Conventions

End of the document

Potrebbero piacerti anche