Regulation 21 CFR

Part 210-211
2
080206
Regulation 21 CFR Part 210-211
The demand for healthcare products is ever in-
creasing as the landscape of modern society
evolves. These trends are reshaping the Pharma-
ceutical and Biologics industries. With the demand
for products, comes the concern among pharma-
bio manufacturers for regulatory scrutiny. Non-
compliance is fscally damaging and potentially
life-threatening, both to a manufacturer and its
customers. Warnings, fnes and recalls ultimately
will impact a companys bottom line, but the real
risk is the potential for human harm.
Taking a proactive approach in addressing the risk
of non-compliance is leading todays drug manu-
facturers to implement a vigorous, enterprise-wide
compliance management solution that can be lev-
eraged to enhance business processes. Organi-
zations are seeking strategies for minimizing their
exposure to risk while staying ahead of the com-
petition in delivering safe and compliant products
to the marketplace.
21 CFR Part 210-211, or Current Good Manufacturing Practices (CGMP) in Manufacturing, Process-
ing, Packing or Holding of Drugs (210); CGMP for Finished Pharmaceuticals (211), require that all
drugs are compliant with the latest GMPs. The regulations ensure that drug products meet regulatory
requirements as to safety, strength, quality and purity.
Pilgrim Software 21 CFR Part 210-211 Reference Chart
Subpart Section Pilgrim Solution(s)
B 211.22 Document Management
211.25 Training Management
211.34 Training Management
F 211.84 Supplier Quality Management
211.100 Document Management
J 211.180 SmartSolve

211.192 CAPA Management

211.198 Complaints Management
B
080206
FDA Requirement Pilgrim Solution
(Subpart B Section 211.22 c, d)*
The quality control unit shall have the responsi-
bility for approving or rejecting all procedures or
specifcations impacting on the identity, strength,
quality, and purity of drug product. The respon-
sibilities and procedures applicable to the quality
control unit shall be in writing; such written proce-
dures shall be followed
Pilgrims electronic Document Management sys-
tem manages all document and procedure ap-
provals. Approval decisions, notes and comments
are maintained for each build of each document
revision. Electronic notifcations and escalations
ensure that the document approval process is
completed in a timely manner.
(Subpart B Section 211.25 a)*
Each person engaged in the manufacture, pro-
cessing, packing or holding of a drug product shall
have education, training, and experience or any
combination thereof to enable that person to per-
form assigned functions. Training shall be in the
particular operations that the employee performs
and in CGMP as they relate to the employees
functions. Training in CGMP shall be conducted
by qualifed individuals on a continuing basis and
with suffcient frequency to assure that employ-
ees remain familiar with CGMP requirements ap-
plicable to them.
Pilgrims Training Management documents em-
ployee skills and employee training to ensure that
employees are adequately trained to perform their
assigned job functions.
Training Management tracks any type of training,
including CGMP training and operational / job re-
lated training.
(Subpart B Section 211.25 c)*
There shall be an adequate number of qualifed
personnel to perform and supervise the manufac-
ture, processing, packing, or holding of each drug
product.
Training Management provides reports and notif-
cations to keep managers informed of employee
skills and employee training needs. Managers
can utilize these reports to ensure an adequate
number of qualifed personnel for each task.
(Subpart B Section 211.34)*
Consultants advising on the manufacture, pro-
cessing, packing, or holding of drug products
shall have suffcient education, training, and ex-
perience, or any combination thereof, to advise on
the subject for which they are retained. Records
shall be maintained stating the name, address,
and qualifcations of any consultants and the type
of service they provide.
Training Management maintains a history of con-
sultant education, training, experience, qualifca-
tions, contact information, etc. All training tracking
features and reports that are available for internal
training records are also available for consultant
training records.
*Source www.fda.gov
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080206
*Source www.fda.gov
FDA Requirement Pilgrim Solution
(Subpart B Section 211.84 b)*
Representative samples of each shipment of
each lot shall be collected for testing or exami-
nation. The number of containers to be sampled,
and the amount of material to be taken from each
container, shall be based upon appropriate crite-
ria such as statistical criteria for component vari-
ability, confdence levels, and degree of precision
desired, the past quality history of the supplier,
and the quantity needed for analysis and reserve
where required by 211.170.
Pilgrims Supplier Quality Management main-
tains supplier quality history as well as supplier
sampling and inspection criteria. Supplier Quality
Management provides inspection records to doc-
ument supplier inspections and tests.
(Subpart F Section 211.100 a, b)*
There shall be written procedures for production
and process control designed to assure that the
drug products have the identity, strength, qual-
ity, and purity they purport or are represented
to possess. These written procedures, including
any changes, shall be drafted, reviewed, and ap-
proved by the appropriate organizational units
and reviewed and approved by the quality control
unit.
Pilgrims Document Management manages any
type of procedure created within an organization,
including procedures for production and process
control. This includes the approval, release, train-
ing, distribution and obsolescence of the proce-
dure.
Document Managements document policies and
templates assure that the appropriate organiza-
tional units participate in the draft, review and ap-
proval of each type of document.
(Subpart J Section 211.180 c)*
All records required under this part, or copies of
such records, shall be readily available for autho-
rized inspection during the retention period at the
establishment where the activities described in
such records occurred. These records or copies
thereof shall be subject to photocopying or other
means of reproduction as part of such inspection.
Records that can be immediately retrieved from
another location by computer or other electronic
means shall be considered as meeting the re-
quirements of this paragraph.
Pilgrims overall SmartSolve

platform maintains
a centralized, 21 CFR Part 11 compliant database
of all quality records including audit records, doc-
uments and document records, training history,
CAPA workfows and history, equipment records
and supplier history.
Records are immediately retrievable through
user friendly searches and reports to be viewed
in electronic format. They may also be printed as
paper copies.
5
080206
FDA Requirement Pilgrim Solution
(Subpart J Section 211.180 e)*
Written records required by this part shall be
maintained so that data therein can be used for
evaluating, at least annually, the quality standards
of each drug product to determine the need for
changes in drug product specifcations or manu-
facturing or control procedures. Written proce-
dures shall be established and followed for such
evaluations
SmartSolve records are maintained for easily re-
trieval as described in Section 211.180 c.
Either Pilgrims Document Management or Audit
Management may be used to manage procedure
evaluations for batches, complaints and other
processes.
(Subpart J Section 211.180 f)*
Procedures shall be established to assure that the
responsible offcials of the frm, if they are not per-
sonally involved in or immediately aware of such
actions, are notifed in writing of any investigations
conducted under 211.198, 211.204, or 211.208 of
these regulations, any recalls, reports of inspec-
tional observations issued by the Food and Drug
Administration, or any regulatory actions relating
to good manufacturing practices brought by the
Food and Drug Administration.
Pilgrims CAPA Management investigations pro-
vide for notifcation to responsible personnel and
offcials if they are not personally involved in an
investigation. This notifcation is pre-defnable to
ensure consistent notifcations and CAPA pro-
cesses. CAPA Management also provides the
fexibility to add notifcations pertinent to a specifc
CAPA record.
(Subpart J Section 211.192)*
Any unexplained discrepancy (including a per-
centage of theoretical yield exceeding the maxi-
mum or minimum percentages established in mas-
ter production and control records) or the failure of
a batch or any of its components to meet any of
its specifcations shall be thoroughly investigated,
whether or not the batch has already been distrib-
uted. ..A written record of the investigation shall
be made and shall include the conclusions and
follow-up.
CAPA Management manages the tracking of any
product discrepancies as well as their associated
investigations. CAPA Management is a closed-
loop CAPA management system that allows users
in any department to initiate a corrective and pre-
ventive action process to address and resolve an
issue. By facilitating an effective CAPA process,
CAPA Management helps to resolve issues quick-
ly and prevent recurrence - ensuring compliance
with industry and regulatory requirements
*Source www.fda.gov
6
080206
FDA Requirement Pilgrim Solution
(Subpart J Section 211.198 a)*
Written procedures describing the handling of all
written and oral complaints regarding a drug prod-
uct shall be established and followed. Such pro-
cedures shall include provisions for review by the
quality control unit.
Pilgrims Complaints Management manages com-
plaint procedures and workfows. This includes
provisions for review by the quality control unit as
well as a determination of the need for an inves-
tigation. Review workfows and personnel notif-
cation may be pre-defned to ensure that the ap-
propriate personnel are notifed of the complaint
and are involved in the appropriate review and
follow-up.
The ability to pre-defne personnel and workfows
drives consistency in the complaint workfow and
ensures that complaints are investigated in an ac-
curate and timely manner.
(Subpart J Section 211.198 b)*
A written record of each complaint shall be main-
tained in a fle designated for drug product com-
plaints. The fle regarding such drug product com-
plaints shall be maintained at the establishment
where the drug product involved was manufac-
tured, processed, or packed, or such fle may be
maintained at another facility if the written records
in such fles are readily available for inspection at
that other facility.
Written records involving a drug product shall be
maintained ..
Items 1, 2 and 3 describe information to be main-
tained within each complaint record.
Complaints Management maintains complaint re-
cords for as long a timeframe as needed to meet
the requirements in this section. Each complaint
record is accessible using Complaints Manage-
ment user-friendly searches and reporting fea-
tures. Since Complaints Management is a web
based application, records are accessible from
any organizational unit or location.
Complaints Managements records document all
of the information described in this requirement,
including the name and strength of the drug prod-
uct, lot number, name of complainant, nature of
complaint, reply to complainant and investigation
/ non-investigation information.
The daily challenges that pharma-bio companies
face are countless. A growing elderly population,
consolidation of the healthcare markets, increased
R&D spending, and expanding product pipelines
require that these manufacturers continue to strin-
gently adhere to regulatory requirements to re-
main competitive. When not met, the consequenc-
es can be fnancially devastating.
Therefore, every process and every practice must
rely on procedures that can be controlled with logi-
cal solutions and well-informed management. The
worlds leading enterprise compliance and quality
management companies, like Pilgrim Software,
are lowering those risks and strengthening the
proftability of organizations, through enterprise-
wide automated solutions. Drug manufacturers
then are able to dedicate their resources to devel-
oping quality products that will directly beneft their
bottom line.
*Source www.fda.gov
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