GOOD AUTOMATED LABORATORY PRACTICE

Good Automated Laboratory
Practices(Part-B)
07-05-2020
1
Presented By: Ms. Jagruti R. Vasava Guided By: Dr.
Kashyap Thummar
M. Pharm (PRA) semester-1
Assistant Professor – Graduate School Of Pharmacy
Gujarat Technological University
Academic Year-2019-2020

Good automated laboratory
practices
A. Training documentation
B. 21 CFR part 11: Electronic records;
Electronic signatures.
07-05-2020
2

Good automated laboratory practices
What is GALP??
• Standardise set of best practices.
• Ensure data gathered, processed, archived.
• Laboratory information management system[LIMS].
Good automated laboratory
practices (GALPs)
• To establish guideline for automated data
management.
• To supply data.
• To US environmental protection agency (EPA).
GALP developed
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A. Training documentation
Content:
I. Introduction
II. Documentation
a) Personnel
b) Laboratory management
c) Responsible person
d) Quality assurance (QA) unit
e) Facilities & equipment
f) Security
g) Software performance
h) Data entry
i) Raw data
j) Reporting
k) Records & archive
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What is Training Documentation?
GALP requires:
• Current summary of personnel training, experience,& job description.
• These all inform. Available for all who involved in design or operation of
automated system.
1.Inclusive training program must established.
2.Documentation must be available that identify not only the quantity of
training each employee receive but, also quality of training.
3.Training program – fully documented ,review at least yearly, new or
upgrade equipment or methodologies are installed.
4. Complete, accurate, appropriate, & all available documentation is necessary
for automated laboratory operation. 07-05-2020
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Personnel Laboratory
management
Raw data
Data entry
Software
performance Security
Facilities &
equipment
Responsible
person
Quality
assurance (QA)
unit
Records &
archived.
Reporting
Training
documentation.
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a. Personnel:
 Backgrounds, including education,
 training, and experience,
 should be documented and available to laboratory management.
 Relevant knowledge of and experience with systems design and operations
should be indicated.
 In light of the need for auditors to verify the qualifications of laboratory
personnel, laboratories may consider a separate education and training file for
each employee.
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b. Laboratory Management:
 It is important for laboratory management to develop an
organizational plan of document and define lines of communication
and reporting within the laboratory structure develop a work plan for
any particular study.
 Laboratory management is responsible to assure that deviations from
the GALP standards are reported and that corrective actions are taken
and documented.
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c. Responsible person:
 Responsible person (RP) must ensure that system documentation is comprehensive,
current, and readily available to users.
 In terms of the RP’s responsibility for assuring adequate acceptance procedures for
software and hardware changes, documentation of acceptance testing can be a part of
the approval process preceding the integration of new or changed software into
laboratory production
 To assure that all applicable GALPs are being followed, the RP should ensure that
copies of GALPs are easily accessible, usually in a designated area, to laboratory
personnel. 07-05-2020
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d. Quality Assurance Unit:
 A major function of the QA unit is to provide proof that the
laboratory’s automated data collection systems operate in an
accurate and correct manner, consistent with the recommended
function.
 The QA unit must have a complete and current set of sops available
and accessible at all times have access to the most current and
version-specific set of operations technical manuals or other
documentation sign off all documentation of inspections maintain
all records and documentation pertaining (related) to its activities,
methodologies, and investigations, including results. 07-05-2020
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e. Facilities and Equipment:
 Written description of the system’s hardware to be maintained.
 Overall description of purpose & use of system & specific listing of hardware & software
involved in data handling are required.
Specific
responsibili
ties
Testing Inspecting Cleaning
and
Maintaining
equipment
Must
assigned
in writing.
Hardware
devices
Appropriate
testing
written
procedures
Must be
maintain
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e. Facilities & equipment cont.…
1. Names of person who conduct tests.
2. Dates.
3. Indication of test results.
4. Documentation of any deviation
procedure.
5. Signature of management & RP who
reviewed.
6. Testing & preventive maintenance by outside
vendors.
7. List of repair malfunctioning(equipment) or
inapropriable equipment.
A log must be
maintain with :
a. Reference.
b. Inspection.
c. Audit.
Document
permanently for:
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f. Security:
Laboratories using automated data collection systems must:-
 Provide security for the systems
 Institute a procedure of documented authorization
 Establish security files
 Appoint a security administrator
 Use a visitors’ log
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g. Software performance:
Methods for determining that software is performing its functions properly must be documented
and followed:
 Written system description (detail information on software’s function).
 Written documentation of Software development standard must be maintained.
 Change control procedure to provide reference & guidance for management of ongoing software
change & maintenance process.
 All steps of process should be explained or clarified and procedure is available to all system
users.
 All algorithm & formula used in programs including : user-developed programs & purchased
software packages that allow entry of formulas or algorithm, must be documented and retained
for future reference and inspection.
 The GALP standards require procedures that document the version of software used to create or
update data sets. 07-05-2020
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h. Data Entry:
 Written procedures and practices must be in place within the laboratory to verify the
accuracy of manually entered and electronically transferred data collected on automated
systems.
 The primary documentation for data entry requirements is an audit trail (traceable & secure
data).
 When data in the system are changed after each initial entry an audit trail must exist that
indicates:
 The new value entered.
 The old value.
 A reason for the change.
 The date of the change.
 The person who entered the change.
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I. Raw Data:
The operational definition
of raw data for the
laboratory, especially as
they relate to the automated
data collection systems
used, must be documented
by the laboratory and made
known to employees.
j. Reporting:
When a laboratory reports data from
analytical instruments electronically
to the EPA, those data must be
submitted on standard magnetic
media—tapes or diskettes—and
conform to all requirements of EPA
order 2180.2, “data standards for
electronic transmission of
laboratory measurement results.”07-05-2020
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k. Records and Archives:
 Schedules, logs, and reports of system backup, system failures, and recoveries or restores.
 Raw data, documentation and records generated in the design and operation of automated
data collection system must be archived in a manner that is orderly and facilitates retrieval.
Storage space :
1. For raw data to retained in hard copy format or in magnetic media.
2. System related records in both electronic & hard copy.
3. Laboratory activities including : complying with reporting & records retention
requirements.
4. for system both on-and off-line storage is required.
 Physical file space requirement must be properly planned & managed to meet lab. Needs
and responsibilities.
 Access all data and documentation archived according to GALP standards.
 Raw data & system related data or documentation of laboratory work submitted in support
of health or environmental programs. 07-05-2020
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B. 21 CFR part 11 [Electronic records;
Electronic signatures].
Content:
1. Introduction
2. Coverage
3. 21 CFR part 11
a. General provision
b. Electronic records
c. Electronic signatures
4. 21 CFR part 11 checklist
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1. Introduction:
Title 21 CFR Part 11 is the part of Title 21 of the Code of
Federal Regulations that establishes the United States Food
and Drug Administration (FDA) regulations on electronic
records and electronic signatures (ER & ES). Part 11, as it is
commonly called, defines the criteria under which electronic
records and electronic signatures are considered trustworthy,
reliable, and equivalent to paper records.
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2. Coverage:
Drug
makers
Medical
device
manufacturer
Biotech
companies
Clinical research
organisation
(CROs)
With some
expectation
Part 11 applies to:
Require implement
controls
Audits
System
validation
Audit
trails
Electronic
signatures
Documentation for
software & system
Involved in
processing
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A. General provision
1. Scope:
• Electronic records,
electronic signatures, and
handwritten signatures.
• Trustworthy, reliable, and
generally equivalent
Paper records &
handwritten signatures
executed on papers
• Electronic form created,
modified, maintained, archived,
retrieved or transmitted under
any records requirements.
• Computer system, controls,
attendant documentation
maintained & available.
FDA inspection.
• Electronic record
submitted to agency
under requirements of
federal food ,drug and
cosmetics act and
public health services
act
Agency regulation
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2. Implementation.
 For records required to be maintained but not submitted to the agency, persons
may use electronic records in lieu of paper records or electronic signatures in lieu
of traditional signatures, in whole or in part, provided that the requirements of this
part are met.
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3. Definitions:
The definitions and interpretations of terms contained in section 201 of the act apply
to those terms when used in this part.
 Act means the Federal Food, Drug, and Cosmetic Act (sec. 201-903 (21 U.S.C.
321-393)).
 Agency means the Food and Drug Administration.
 Closed system: means an environment in which system access is controlled by
persons who are responsible for the content of electronic records that are on the
system.
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3. Definitions cont...
Electronic record: means any combination of text, graphics, data, audio,
pictorial, or other information representation in digital form that is
created, modified, maintained, archived, retrieved, or distributed by a
computer system.
Electronic signature: means a computer data compilation of any symbol
or series of symbols executed, adopted, or authorized by an individual to
be the legally binding equivalent of the individual's handwritten
signature.
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3. Definitions cont.….
Handwritten signature: means the scripted name or legal mark of
an individual handwritten by that individual and executed or
adopted with the present intention to authenticate a writing in a
permanent form.
Open system: means an environment in which system access is not
controlled by persons who are responsible for the content of
electronic records that are on the system.
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B. Electronic Records
a) Controls for closed systems:
Such procedures and controls shall include the following:
Validation of
system
• Ensure accuracy, reliability, consistent intended
performance
Ability to
• Discern invalid & complete copies of records.
• Human readable & electronic form suitable for inspection, review &
copying by the agency.
Use of device.
• Check to determine, as appropriate,
validity of source of data input or
operational instruction. 07-05-2020
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Control for closed system cont.…
Use of operational system checks to enforce permitted sequencing
of steps and events, as appropriate.
Use of appropriate controls over systems documentation including:
(1) Adequate controls over the distribution of, access to, and use of
documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit trail
that documents time-sequenced development and modification of
systems documentation.
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b). Controls for open systems.

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Person who use open system:
To Create, modify, maintain, or transmit electronic records
Shall employ procedure and control designed
To Ensure the authenticity, integrity, and as appropriate
confidentiality of electronic records
From the point of their creation to the point of their receipt.

c). Signature manifestations.
Signed electronic records shall contain information associated
with the signing that clearly indicates all of the following:
(1)The printed name of the signer;
(2)The date and time when the signature was executed; and
(3)The meaning (such as review, approval, responsibility, or
authorship) associated with the signature.
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d). Signature/record linking.
Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic
records to ensure that the signatures cannot be excised, copied, or
otherwise transferred to falsify(to changes) an electronic record
by ordinary means.
07-05-2020
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C. Electronic Signatures
1) General requirements:
 Each electronic signature shall be unique to one individual and shall not be
reused by, or reassigned to, anyone else.
 Before an organization establishes, assigns, certifies, or otherwise sanctions
an individual's electronic signature, or any element of such electronic
signature, the organization shall verify the identity of the individual.
 Persons using electronic signatures shall, at the time of such use, certify to
the agency that the electronic signatures in their system, used on or after
August 20, 1997, are intended to be the legally binding equivalent of
traditional handwritten signatures. 07-05-2020
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2). Electronic signature components and controls.
Electronic signature components and controls.
(A) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as an
identification code and password.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an
individual's electronic signature by anyone other than its genuine owner
requires collaboration of two or more individuals.
 (B) Electronic signatures based upon biometrics shall be designed to
ensure that they cannot be used by anyone other than their genuine
owners. 07-05-2020
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3). Controls for identification codes/passwords
Persons who use electronic signatures based upon use of identification codes in
combination with passwords shall employ controls to ensure their security and
integrity. Such controls shall include:
(a) Maintaining the uniqueness of each combined identification code and
password, such that no two individuals have the same combination of
identification code and password.
(b) Ensuring that identification code and password issuances are periodically
checked, recalled, or revised (e.g., to cover such events as password aging).
07-05-2020
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Control for identification code/passwords
cont.…
Initial and periodic testing of devices, such as tokens or
cards, that bear or generate identification code or
password information to ensure that they function
properly and have not been altered in an unauthorized
manner.
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3. 21 CFR part 11 checklist:
 This checklist was prepared by analysing each clause of this document for the key
words that signify following:
07-05-2020
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Key words for
checklist
Policy
Procedure
Plan
RecordsDocuments
Audit
Review

21 CFR part 11 checklist cont.….
This checklist specifies evidence that is unique to the
process necessary for electronic records and electronic
signatures.
The information was transferred into checklist tables,
based on the type of product or evidence.
 21CFRPart11 Checklist Sample.pdf
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References:
Good regulatory practice regulation, third edition, revised and expand,
edit by GERALDJ.WHARTENBY, PAULL.ROBINSON, and
SANDYWEINBERG, Muhlenberg College Allentown, Pennsylvania,
U.S.A., Copyright © 2003 Marcel Dekker, Inc. 154-161.
https://en.wikipedia.org/wiki/Title_21_CFR_Part_11. Pg.1, 2&3,
28/9/2019
https://www.fda.gov/, title 21- food and drugs, chap-1 food and drug
administration department of health and human services subchapter A ,
part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES,
source 62 FR 13464, mar.20,1997.
http://www.techstreet.com/direct/21CFRPart11_sample.pdf. 07-05-2020
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