21 CFR Part 11.pptx

21 CFR PART 11 &
WHO-GMP
REQUIREMENTS
Name:- Urvi Patel
Department:-Pharmaceutical QualityAssurance

CONTENTS
21-Aug-23 2
 Code of Federal Regulation (CFR) 21 CFR
 21 CFR Part 11
 Part 11: Electronic Records & Electronic Signatures :-
Subpart A - General Provisions
Subpart B - Electronic Records
Subpart C – Electronic SignaturesGood Manufacturing Practices Quality Management Documentation
 Range of requirements for written procedures Standard operating procedures (SOPs)
 Format for standard operating procedures (SOPs) Forms for recording data
 Master formulae
 References

WHAT ISCFR?
The Code of Federal Regulations (CFR) is the codification of the general
and permanent rules published in the Federal Register by the
Executive departments and agencies of the Federal Government.
• It is divided into 50 titles that represent broad areas subject
to Federal regulation.
• Each volume of the CFR is updated once each calendar
• year and is issued on a quarterly basis.
• Titles 1-16 are updated as of January 1st
• Titles 17-27 are updated as of April 1st
• Titles 28-41 are updated as of July 1st
• Titles 42-50 are updated as of October 1st
21-Aug-23 3
C
F
R
CODE OF
FEDERAL
REGULATIONS

WHAT IS CFR ?
• The volumes of the CFR are jointly produced
by the National Archives and Record
Administration’s (NARA), Office of the
Federal Register (OFR), and the Government
Publishing Office (GPO) to provide the public
with access to authentic government information
21-Aug-23 4
Titles
Chapters
Subchapters
Parts
Subparts

WHAT IS 21 CFR?
21-Aug-23 5
▪ The 21 CFR and its recommendations are very important in today's pharmaceutical industry.
▪ Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the
United States for three of its governing bodies:
Food and Drug
Administration
(FDA)
Drug
Enforcement
Agency
(DEA)
Office of
National Drug
Control
Policy
(ONDCP)

▪ 21 CFR Part 11 is the FDA's regulations for electronic records and electronic signatures.
▪ It outlines the administration of electronic records in a medical device company’s quality management
system.
▪ Since 21 CFR Part 11 was first published in 1997, our electronic systems and their capabilities have
advanced enormously.
WHAT IS 21 CFR PART 11 ?
21-Aug-23 6

PART 11 ELECTRONIC RECORDS; ELECTRONIC
21-Aug-23 8
▪ Subpart A - General Provisions
11.1 - Scope.
11.2 - Implementation.
11.3 - Definitions.
▪ Subpart B - Electronic Records
11.10 - Controls for closed systems.
11.30 - Controls for open systems.
11.50 - Signature manifestations.
11.70 - Signature/record linking.
▪ Subpart C - Electronic Signatures
11.100 - General requirements.
11.200 - Electronic signature components and controls.
11.300 - Controls for identification codes/passwords.
SIGNATURE

SUBPART A –
G ENER A L PROVISIONS
21-Aug-23 9

SEC. 11.1 SCOPE
21-Aug-23 10
1) Electronic records to be trustworthy, reliable, and generally equivalent to paper
records
2) Records in electronic form that are created, modified, maintained, archived,
retrieved, or transmitted,
3) Electronic signatures to be equivalent to full handwritten signatures, initials, and
other general signings........ effective on or after August 20, 1997.
4) Electronic records may be use in lieu of paper records
5) Computer systems (including hardware and software).

SEC.11.2IMPLEMENTATION.
21-Aug-23 11
a) For records required to be maintained but not submitted to the agency, --
provided that the requirements of this part are met.
b) For records submitted to the agency
1) The requirements of this part are met
2) document to be submitted have been identified in public docket No. 92S–0251

SEC.11.3DEFINITIONS.
21-Aug-23 12
Act means the Federal Food, Drug, and CosmeticAct.
Agency means the Food and DrugAdministration.
Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable
action(s) where those features and/or actions are both to that individual and measurable.
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.
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.
Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of
rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

CONTI….
21-Aug-23 13
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.
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. The act of signing with a writing or marking instrument such as a pen or
stylus is preserved.The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture
the name or mark.

SUBPART B –
E L E C T R O N I C RECORDS
21-Aug-23 14

▪ Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ
procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the
confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed
record as not genuine. Such procedures and controls shall include the following:
▪ Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to
discern invalid or altered records.
▪ The ability to generate accurate and complete copies of records in both human readable and electronic
form suitable for inspection, review, and copying by the agency. Persons should contact the agency if
there are any questions regarding the ability of the agency to perform such review and copying of the
electronic records.
▪ Protection of records to enable their accurate and ready retrieval throughout the records retention
period.
SEC.11.10 CONTROLS FOR CLOSED
SYSTEMS.
21-Aug-23 15

Conti..
21-Aug-23 16
▪ Limiting system access to authorized individuals.
▪ Use of secure, computer-generated, time-stamped audit trails to independently record the date and time
of operator entries and actions that create, modify, or delete electronic records. Record changes shall not
obscure previously recorded information. Such audit trail documentation shall be retained for a period at
least as long as that required for the subject electronic records and shall be available for agency review
and copying.
▪ Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
▪ Use of authority checks to ensure that only authorized individuals can use the system, electronically
sign a record, access the operation or computer system input or output device, alter a record, or perform
the operation at hand.
▪ Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data
input or operational instruction.

Conti…
21-Aug-23 17
▪ Determination that persons who develop, maintain, or use electronic record/electronic signature systems
have the education, training, and experience to perform their assigned tasks.
▪ The establishment of, and adherence to, written policies that hold individuals accountable and
responsible for actions initiated under their electronic signatures, in order to deter record and signature
falsification.
▪ Use of appropriate controls over systems documentation including:
▪ Adequate controls over the distribution of, access to, and use of documentation for system operation
and maintenance.
▪ Revision and change control procedures to maintain an audit trail that documents time-sequenced
development and modification of systems documentation.

▪ Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ
procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation to the point of their receipt.
▪ Such procedures and controls shall include those identified in § 11.10, as appropriate, and additional
measures such as document encryption and use of appropriate digital signature standards to ensure, as
necessary under the circumstances, record authenticity, integrity, and confidentiality.
SEC. 11.30 CONTROLS FOR OPEN SYSTEMS.
21-Aug-23 18

a) 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.
b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same
controls as for electronic records and shall be included as part of any human readable form of the electronic
record (such as electronic display or printout).
SEC. 11.50 SIGNATURE MANIFESTATIONS.
21-Aug-23 19

▪ 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 an electronic record by ordinary means.
SEC. 11.70 SIGNATURE/RECORD LINKING
21-Aug-23 20

SUBPART C –
E L E C T R O N I C SIGNATURES
21-Aug-23 21

▪ 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, prior to or 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.
a) The certification shall be submitted in paper form and signed with a traditional handwritten signature,
to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
b) Persons using electronic signatures shall, upon agency request, provide additional certification or
testimony that a specific electronic signature is the legally binding equivalent of the signer's
handwritten signature.
SEC. 11.100 GENERAL REQUIREMENTS.
21-Aug-23 22

SEC. 11.200 ELECTRONIC SIGNATURE
COMPONENTSAND CONTROLS.
• Electronic signatures that are not based upon biometrics shall:
• Employ at least two distinct identification components such as an identification code and
password.
1. When an individual executes a series of signings during a single, continuous period of
controlled system access, the first signing shall be executed using all electronic signature
components; subsequent signings shall be executed using at least one electronic
signature component that is only executable by, and designed to be used only by, the
individual.
2. When an individual executes one or more signings not performed during a single,
continuous period of controlled system access, each signing shall be executed using all of
the electronic signature components.
21-Aug-23 23

SEC. 11.200 ELECTRONIC SIGNATURE
COMPONENTS AND CONTROLS.
a) Be used only by their genuine owners; and
b) 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.
• Electronic signatures based upon biometrics shall be designed to ensure that they cannot
be used by anyone other than their genuine owners.
21-Aug-23 24

▪ 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:
1. Maintaining the uniqueness of each combined identification code and password, such that no two
individuals have the same combination of identification code and password.
2. Ensuring that identification code and password issuances are periodically checked, recalled, or
revised (e.g., to cover such events as password aging).
3. Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise
potentially compromised tokens, cards, and other devices that bear or generate identification code or
password information, and to issue temporary or permanent replacements using suitable, rigorous
controls.
SEC. 11.300 CONTROLS FOR
IDENTIFICATION CODES/PASSWORDS.
21-Aug-23 25

4. Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes,
and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to
the system security unit, and, as appropriate, to organizational management.
5. 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.
SEC. 11.300 CONTROLS FOR
IDENTIFICATION CODES/PASSWORDS.
21-Aug-23 26

WHO -
GMP R E Q U I R E ME N T S
21-Aug-23 27

▪ WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that
products are consistently produced and controlled to the quality standards appropriate to their intended use
and as required by the marketing authorization.”
▪ GMP covers all aspects of the manufacturing process:
▪ defined manufacturing process;
▪ validated critical manufacturing steps;
▪ suitable premises, storage, transport;
▪ qualified and trained production and quality control personnel;
▪ adequate laboratory facilities;
▪ approved written procedures and instructions;
▪ records to show all steps of defined procedures taken;
▪ full traceability of a product through batch processing records and distribution records;
▪ systems for recall and investigation of complaints.
GOOD MANUFACTURING PRACTICES (GMP)
21-Aug-23 28

▪ The guiding principle of GMP is that quality is built into a product, and not just tested into a finished
product.
▪ Therefore, the assurance is that the product not only meets the final specifications, but that it has been made
by the same procedures under the same conditions each and every time it is made.
▪ There are many ways this is controlled- quality of the facility and its
systems
quality of the starting materials,
quality of production at all
stages
quality of the testing of the product
identity of materials by adequate
labeling and segregation
quality of materials and product by
adequate storage
All of these controls must
follow prescribed, formal,
approved procedures,
written as protocols, SOPs,
or Master Formulae,
describing all
carried out in
the tasks
an entire
manufacturing and control
process.
CONTROLLING
GOOD MANUFACTURING PRACTICES (GMP)
21-Aug-23 29

QUALITY MANAGEMENT
21-Aug-23 30
▪ The basic elements of quality management are:
▪ An appropriate infrastructure or “quality
system”, encompassing the organizational
structure, procedures, processes, and
resources; and
▪ Systematic actions necessary to ensure
adequate confidence that a product (or
service) will satisfy given requirements for
quality. The totality of these actions is
termed “quality assurance”.
▪ The concepts of quality assurance, GMP, and
quality control are interrelated aspects of quality
management. They are of “fundamental
importance to the production and control of
pharmaceutical products”.
Quality Control
Good
Manufacturing
Practices
Quality Assurance
Quality
Management
System

▪ QA encompasses all of the arrangements made to ensure that pharmaceutical products meet the quality
required for their intended use.
▪ Although QA is not specified in all GMP documents, the WHO GMP guidelines (ref 27) present the
principles of QA are to ensure that GMP and other regulatory codes (GLP - Good Laboratory Practice, and
GCP - Good Clinical Practice) are respected; that responsibilities are clearly specified; all testing, controls,
calibrations, validations, etc are performed as specified; that products are not sold before the correct
authorizations have been obtained; that products are appropriately handled throughout their shelf-life; and
that there is a procedure for self inspections (quality audit).
▪ All GMP Regulations or Guidelines agree that the independence of quality control from production is
fundamental.
▪ QC specifically involves sampling, determining specifications, and testing and approving of starting
materials, intermediate and final product; maintaining records of all sampling, inspecting, testing;
ensuring that deviations are recorded and investigated; retaining sufficient samples to permit future
examination; and to ensure that no product is released without the certification required by the marketing
authorization (product licence, registration certificate).
QUALITY MANAGEMENT
21-Aug-23 31

▪ Depending on the size of a pharmaceutical manufacturer, the number of products manufactured, the
complexity of the operations, and the requirements of the local regulatory authorities, the system of “quality
management” will differ.
▪ A company can range from:
i. A small single product facility with a production and QC department and a quality assurance
programme which performs quality audits with a team comprised of staff from the two departments;
to:
ii. A large multi-product company with production, quality control, quality assurance, engineering, and
regulatory affairs departments. Provided that the quality assurance system, incorporating GMP and
quality control, is well planned, with all functions specified and appropriately implemented, and the
regulatory requirements taken into account, the allocation of specific duties to QA and QC may vary.
▪ When writing SOPs, the section identifying the responsibilities for approvals or authorizations will reflect
the quality management structure of the company.
QUALITY MANAGEMENT
21-Aug-23 32

▪ Documentation is the key to operating a pharmaceutical company in
compliance with GMP requirements.
▪ The system of documentation devised or adopted should have as its main
objective to establish, monitor, and record "quality" for all aspects of the
production and quality control.
▪ Several types of documents are needed to accomplish this.
▪ Standard operating procedures, specifications and master formulae
▪ Forms for recording data
▪ Identification numbers
▪ Labels
21-Aug-23 33
DOCUMENTATION

DOCUMENTATION
21-Aug-23 34
▪ Standard operating procedures, specifications and master formulae
▪ Descriptive documents give instructions on how to perform a procedure or a study, or give a description
of specifications. The instruction type documents are: standard operating procedures (SOP); protocols
(for validation studies, stability studies, safety studies); and master formulae (manufacturing
instructions).
▪ Each of these gives instruction on how to perform specific procedures. Specifications describe the
required characteristics or composition of a product or material or test.
▪ These kinds of documents provide the specific details defining the quality of incoming materials, the
quality of the production environment, the quality of the production and control process, and the
quality of the final product.

DOCUMENTATION
21-Aug-23 35
▪ Forms for recording data:
▪ Another type of documentation is the form used for recording data as it is taken during the performance
of tasks, tests, or events.
▪ These are forms (datasheets, or data record forms), reports, batch processing records, and equipment log
books.
▪ These documents provide the evidence that the raw materials, facility environment, the production
process, and the final product consistently meet the established quality requirements.

DOCUMENTATION
21-Aug-23 36
▪ Identification numbers:
▪ There are also the identification systems or codes devised to number and track both information and
documents.
▪ These are SOP numbers, equipment numbers, form numbers, receiving codes, and batch/lot numbers.
▪ These numbering systems should be designed so that procedures, processes and materials can be traced
throughout the data records.

DOCUMENTATION
21-Aug-23 37
▪ Labels:
▪ Labeling systems are used to identify the status of the equipment or facility, restricted areas, and
warning labels. These include raw material tags, quarantine labels, release labels, reject labels, labels to
identify specific storage areas, biohazard or radioactive labels, restricted access labels, equipment
"cleaned" or "waiting for cleaning" labels, process intermediate labels, and the final product labels.
These permit the identification and tracking of materials, of the progress of a production process, and
assurance of the proper functioning of equipment.
▪ The WHO guidelines for Good Manufacturing Practices (ref. 21, 27) and all other national and
international GMP Guidelines and Regulations (ref. 3, 5, 7, 11, 18, 19) emphasize the requirement for
complete documentation. A well-structured documentation system, including SOPs for the regular
document review and revision, provides the structure for recording the evidence for the quality of the
product.
▪ All documentation must be organized into files which must be maintained for specified periods of
time after the expiry date of the product.

DOCUMENTATION
21-Aug-23 38
▪ A well-designed documentation system is useful only if it is well used. The system must include quality
assurance procedures to ensure that instructions are followed, that labels and numbering systems are
properly used and recorded, and that data record forms and batch processing records are assembled and
reviewed.
▪ Control and assessment of the documentation system itself is a significant management tool that permits
an ongoing assessment of the changes and revisions necessary to remain in compliance, to delete what is
unnecessary or redundant and to improve procedures or processes.

▪ Throughout the WHO GMP Guidelines, in addition to sections on document requirements, many references
are made to the need for written procedures for specific aspects of the manufacturing process. There is a
broad range of SOPs needed for a pharmaceutical manufacturing establishment. GMP Guidelines and
Regulations for pharmaceuticals, sterile products, and biologicals from WHO, the EU and several other
countries make reference to ‘written procedures” throughout the documents.
▪ A review of WHO’s GMP Requirements for reference to "written procedures" resulted in a long list of
operations and activities which must follow written approved procedures. The list covered the requirements
for all aspects of the control of quality: raw materials and packaging materials, the premises, the
equipment, the test procedures, the production, personnel performance, and quality assurance.
RANGE OF REQUIREMENTS FORWRITTEN
PROCEDURES
21-Aug-23 39

▪ Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or
administrative procedure is to be performed, or how a piece of equipment is operated, maintained and
calibrated.
▪ SOPs describe the "standard" approved procedures that are routinely carried out in a GMP facility.
▪ They indicate exactly how things are done, and are kept current by review and approved revision on a
predetermined schedule (usually annual), or when planned changes are made to the procedure or
equipment and reagents used in the procedure.
▪ The original of a current version of an SOPs is maintained in a central file, and copies are distributed to
the locations where the procedure is performed.
▪ The procedure for describing the writing, revising and approving of SOPs and the control of distribution of
SOPs is one of the important quality assurance procedures.
▪ The term “change control” has recently been introduced to the vocabulary of pharmaceutical
manufacturing and control. Although this is primarily a term for validation procedures, it may also apply
to the control of the review and revision of SOPs for routine procedures.
STANDARD OPERATING PROCEDURES
(SOPS)
21-Aug-23 40

▪ Any SOP describing the distribution and control of documents must clearly indicate the mechanisms by
which SOPs can be modified or changed: from assessment and rationale for the need for a change, to the
evaluation of other SOPs that might be changed as a result, to the final approval of changes and the
implementation of the changed procedure.
▪ SOPs are used as a reference by the persons responsible for the performance, and are also used for training
new operators in the performance of the procedure.
▪ Quality assurance procedures should be in place to ensure that SOPs are enforced and properly used.
▪ SOPs follow a scientific format, and are written with the view that they will be used by persons trained in
the procedure. They should be specific instructions for each step in sequential order including the
preparatory work which must be done before starting the main procedure, as well as instructions for
recording and reporting the results.
▪ There is little need for excess text on theory and background - what is required is clear concise instructions
for carrying out a procedure which has been approved.
(SOPS)
21-Aug-23 41

▪ Usually the initial draft of an SOP is written by the person performing the procedure or by someone who
knows the procedure well and must be written including the details and the time course of the tasks.
Supervisors review the SOPs for completeness and content and QC or QA staff approve for regulatory
compliance.
▪ When appropriate, a formal data sheet or data record form is prepared for an SOP.
▪ This form is a parallel summary document with checklists, checkboxes, and blanks for all data to be
recorded during the performance of the procedure. It also has spaces for signatures of the operator and
other technicians who verify and countersign certain critical operations during the procedure. Finally, there
is the space for the signature of the department supervisor who reviewed the completed data record form.
Such blanks and checklists ensure that the required data are collected, that nothing is overlooked and also
provide the evidence that the procedure was performed according to the SOP. The datasheets also
provide instructions for recording deviations to the procedure, for calculations or reporting requirements, for
comparison of results with predetermined specifications, and the criteria for repeating procedures in cases
where unacceptable results were obtained.
(SOPS)
21-Aug-23 42

▪ The instructions for the manufacturing method are also written procedures but are not called SOPs. The
full procedure is detailed in a Master Formula which details the preparations to be made, the equipment
to be used, and the method to be followed.GMP documents from WHO and other countries all require
that a Master Formula be prepared and approved for each batch size of every product manufactured.
▪ The Master Formula describes in detail all the manufacturing instructions for that specific batch of
product.
▪ The MF explains detailed step-by-step instructions for the production process: the details include the
specific types and amounts of components and raw materials; the details of the processing parameters;
indicates what in process quality controls are required; specifications for intermediates; environmental
monitoring and control.
▪ The MF is written with blank spaces at each point where data or information is to be recorded to document
that the production events occurred as directed. For some steps, the MF may refer to an SOP which
describes a specific part of the production process.
MASTER FORMULAE
21-Aug-23 43

▪ In various GMP documents, the term for this master document differs slightly. WHO and Canada use the
term “Master Formulae”; in the USA GMP Regulations the term is “Master Production and Control
Record”; in the EU GMP guidelines the term is “Manufacturing Formulae and Processing Instructions”, and
the Australian GMP Guidelines calls it “Master Formulae and Processing Instructions”. However, regardless
of the term used, the information to be provided is essentially the same in each of these GMP documents.
▪ The MF can be prepared as a set of documents: one for each segment of the full production process (e.g. for
the production of an intermediate such as a batch of harvest or for the formulation/filling process from final
bulk), or a single overall document that contains parts which describe the separate batch products that make
up the full process from the starting materials to the final vialed product.
▪ If the MFs are prepared for batches of intermediate products, there will be several documents which
together describe the full production process for a particular product from beginning to end. If the MF
describes the full process, then the parts of the MF will describe production process for an intermediate
product..
MASTER FORMULAE
21-Aug-23 44

▪ The sections described in the MF should correspond to the chronological operations for the major
manufacturing steps. It should have a first section with component preparation such as cleaning,
equipment preparation, raw material preparation, etc. (It can be convenient to divide the sections up on a
day-by-day basis).
▪ There must be spaces provided for approval initials for each step as it is performed, and any deviations that
may occur must be recorded at the time in the margins.
▪ Verification signatures or initials of another operator may be required for critical processes and space should
be provided accordingly for these steps. Space for review by a supervisor must be included. All products,
equipment and facility areas listed in the MF should have reference numbers associated with them to permit
traceability.
▪ The format for the MF should be a formal document with the company name, product name, batch size,
site of manufacture, a document number with revision number, and approval signatures and dates.
Each page should be numbered and spaces should be provided to fill in the lot number of the batch and for
approval signatures.
MASTER FORMULAE
21-Aug-23 45

▪ The MF, and any revisions, must be approved, with dated signatures, by both Production and QA officials.
The original should be filed in a safe place and approved copies are made for each production run. The lot
number of the batch is filled in on each page, and approval signatures and information are filled in as
required and distributed for use for each production order. An SOP describing the writing, approval,
distribution and use of the MF should be prepared.
▪ Batch Processing Records:
▪ A batch processing record is built up by filling in all the blanks on an approved Master Formulae
sheets.
▪ An approved copy of the MF is requested by the production department for each production run of a
batch.
▪ The Batch Processing Record Document must be verified by QA or QC as an exact replica of the
current MF before being released for a batch production run.
▪ It is ideal to have the batch processing record divided by day (see format in later section of this guide)
so that only the required blank pages of the batch processing record are taken into the production area
for each day of a production run.
MASTER FORMULAE
21-Aug-23 46

▪ Batch:
▪ Batches are defined as a specific quantity of a drug or material that is produced in a single
manufacturing operation having a uniform character and quality and which meets predetermined
specifications.
▪ Depending on the production method of the material being manufactured, a batch can be the result of a
continuous production process of a drug, or a defined part of the production process.
▪ For example, a batch can be the production of a crude harvest of a bacterial or viral vaccine from a
fermentation run; or it can be a bulk purified product manufactured from raw materials or from crude
harvest; or it can be the formulation and filling of a bulk into the final container product.
▪ In each of these examples, the “batch” is the product of a process with a defined starting and ending
point, and usually with a storage period at both beginning and end. Each of these separate production
events would have a separate batch record documenting the procedures and process parameters carried
out.
MASTER FORMULAE
21-Aug-23 47

REFERENCE
21-Aug-23 48
▪ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
▪ A WHO guide to good manufacturing practice (GMP) requirements by Global Training Network.

21 CFR Part 11.pptx

Recommended

Recommended

More Related Content

Similar to 21 CFR Part 11.pptx

Similar to 21 CFR Part 11.pptx (20)

Recently uploaded

Recently uploaded (20)

21 CFR Part 11.pptx