Top 20 observation series # 5 21 CFR 211.100

21 CFR 211.100
pharmauptoday@gmail.comConsult Yourself.... “Know Regulation - No Observation”

- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.100
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
pharmauptoday@gmail.com
Contents

Total Inspectional Observations
Center Name 483s Issued
Foods 2476
Devices 972
Drugs 645
Veterinary Medicine 337
Bioresearch Monitoring 297
Biologics 146
Human Tissue for Transplantation 115
Parts 1240 and 1250 70
Radiological Health 16
Sum Product Area 483s from System* 5074
Actual Total in System 483s** 4943
Number of 483s Issued from the System*
Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM

Inspectional Observations - Drugs
Summary Count (Number)
Total 483’s issued for Drugs center in 2014 645
Total number of observations issued for Drugs center in 2014 2997
Total number of observations related to cGMP (21 CFR part 211) violations 2835
Total number of top 10 CFR part 211 violation 1653 (58%)
Number of CFR part 211 parts violated 54

S.No. CFR Frequency % S.No. CFR Frequency % S.No. CFR Frequency %
1 21 CFR 211.160 235 8.3 19 21 CFR 211.186 48 1.7 37 21 CFR 211.204 10 0.4
2 21 CFR 211.22 218 7.7 20 21 CFR 211.63 41 1.4 38 21 CFR 211.101 9 0.3
3 21 CFR 211.192 209 7.4 21 21 CFR 211.80 41 1.4 39 21 CFR 211.105 6 0.2
4 21 CFR 211.67 184 6.5 22 21 CFR 211.142 32 1.1 40 21 CFR 211.115 6 0.2
5 21 CFR 211.100 167 5.9 23 21 CFR 211.167 32 1.1 41 21 CFR 211.134 6 0.2
6 21 CFR 211.165 143 5.0 24 21 CFR 211.170 31 1.1 42 21 CFR 211.82 6 0.2
7 21 CFR 211.42 143 5.0 25 21 CFR 211.125 29 1.0 43 21 CFR 211.196 5 0.2
8 21 CFR 211.113 128 4.5 26 21 CFR 211.56 28 1.0 44 21 CFR 211.44 5 0.2
9 21 CFR 211.166 115 4.1 27 21 CFR 211.150 23 0.8 45 21 CFR 211.48 4 0.1
10 21 CFR 211.25 111 3.9 28 21 CFR 211.46 20 0.7 46 21 CFR 211.52 4 0.1
11 21 CFR 211.68 99 3.5 29 21 CFR 211.122 19 0.7 47 21 CFR 211.184 3 0.1
12 21 CFR 211.198 95 3.4 30 21 CFR 211.130 19 0.7 48 21 CFR 211.86 3 0.1
13 21 CFR 211.84 91 3.2 31 21 CFR 211.58 18 0.6 49 21 CFR 211.87 3 0.1
14 21 CFR 211.110 89 3.1 32 21 CFR 211.182 17 0.6 50 21 CFR 211.34 2 0.1
15 21 CFR 211.194 83 2.9 33 21 CFR 211.103 14 0.5 51 21 CFR 211.65 2 0.1
16 21 CFR 211.188 74 2.6 34 21 CFR 211.137 13 0.5 52 21 CFR 211.89 2 0.1
17 21 CFR 211.180 72 2.5 35 21 CFR 211.111 12 0.4 53 21 CFR 211.176 1 0.0
18 21 CFR 211.28 53 1.9 36 21 CFR 211.94 11 0.4 54 21 CFR 211.208 1 0.0
21 CFR 211 Observations - Drugs

21 CFR 211 Observations - Drugs
0
50
100
150
200
250
21CFR211.22
21CFR211.25
21CFR211.28
21CFR211.34
21CFR211.42
21CFR211.44
21CFR211.46
21CFR211.48
21CFR211.52
21CFR211.56
21CFR211.58
21CFR211.63
21CFR211.65
21CFR211.67
21CFR211.68
21CFR211.80
21CFR211.82
21CFR211.84
21CFR211.86
21CFR211.87
21CFR211.89
21CFR211.94
21CFR211.100
21CFR211.101
21CFR211.103
21CFR211.105
21CFR211.110
21CFR211.111
21CFR211.113
21CFR211.115
21CFR211.122
21CFR211.125
21CFR211.130
21CFR211.134
21CFR211.137
21CFR211.142
21CFR211.150
21CFR211.160
21CFR211.165
21CFR211.166
21CFR211.167
21CFR211.170
21CFR211.176
21CFR211.180
21CFR211.182
21CFR211.184
21CFR211.186
21CFR211.188
21CFR211.192
21CFR211.194
21CFR211.196
21CFR211.198
21CFR211.204
21CFR211.208

List of “Top 20 – CFR parts to know”
S.No. CFR Frequency %
1 21 CFR 211.160 235 8.3
2 21 CFR 211.22 218 7.7
3 21 CFR 211.192 209 7.4
4 21 CFR 211.67 184 6.5
5 21 CFR 211.100 167 5.9
6 21 CFR 211.165 143 5.0
7 21 CFR 211.42 143 5.0
8 21 CFR 211.113 128 4.5
9 21 CFR 211.166 115 4.1
10 21 CFR 211.25 111 3.9
11 21 CFR 211.68 99 3.5
12 21 CFR 211.198 95 3.4
13 21 CFR 211.84 91 3.2
14 21 CFR 211.110 89 3.1
15 21 CFR 211.194 83 2.9
16 21 CFR 211.188 74 2.6
17 21 CFR 211.180 72 2.5
18 21 CFR 211.28 53 1.9
19 21 CFR 211.186 48 1.7
20 21 CFR 211.63 41 1.4
Total 2398 85
• The top 10 cGMP violations (21
CFR part 211 observations)
comprises a huge percentage
(58% i.e. 1653 number of
observations).
• The top 20 cGMP violations (21
CFR part 211 observations)
comprises a huge percentage
(85% i.e. 2398 number of
observations).
• If the top 20 violations are
eliminated, 85 % of the
observations can be reduced.

Subpart I--Laboratory Controls
Sec. 211.160 General requirements.
21 CFR 211.160 (a)
21 CFR 211.160 (b)
21 CFR 211.160 can be accessed from the link:
http://www.slideshare.net/skvemula/top-20-observation-
series-1-21-cfr-211160
21 CFR 211.160

Subpart B--Organization and Personnel
Sec. 211.22 Responsibilities of quality control unit.
21 CFR 211.22 (a)
21 CFR 211.22 (b)
21 CFR 211.22 (c)
21 CFR 211.22 (d) can be accessed from the link:
21 CFR 211.22

Subpart J--Records and Reports
Sec. 211.192 Production record review.
21 CFR 211.192 can be accessed from the link:
21 CFR 211.192

Subpart D--Equipment
Sec. 211.67 Equipment cleaning and maintenance.
21 CFR 211.67(a)
21 CFR 211.67(b)
21 CFR 211.67(c) can be accessed from the link:
21 CFR 211.67

Subpart F- Production and Process Controls
Sec. 211.100 Written procedures; deviations.
21 CFR 211.100(a)
21 CFR 211.100(b)
21 CFR 211.100

483 citations related to 21 CFR 211.100
Year Number
2006 202
2007 164
2008 117
2009 179
2010 241
2011 233
2012 226
2013 218
2014 167
0
50
100
150
200
250
300
2006 2007 2008 2009 2010 2011 2012 2013 2014
483 Observations

Regulation

CFR part 211 Regulation - 21 CFR 211.100(a)
Subpart F--Production and Process Controls
• Sec. 211.100 Written procedures; deviations.
(a) There shall be written procedures for production and process control designed to
assure that the drug products have the identity, strength, quality, and purity they purport or
are represented to possess.
Such procedures shall include all requirements in this subpart. These written
procedures, including any changes, shall be drafted, reviewed, and approved by the
appropriate organizational units and reviewed and approved by the quality control unit.

Previous observations

483 citations related to 21 CFR 211.100(a)
Cite Id
Reference
Number
Short Description Long Description
Frequency
2014 2013
1361
21 CFR
211.100(a)
Absence of Written
Procedures
There are no written procedures for production and process
controls designed to assure that the drug products have the
identity, strength, quality, and purity they purport or are
represented to possess. Specifically, ***
87 106
3571
21 CFR
211.100(a)
Changes to Procedures
Not Reviewed, Approved
Changes to written procedures are not [drafted, reviewed
and approved by the appropriate organizational unit]
[reviewed and approved by the quality control unit].
Specifically, ***
14 17
3570
21 CFR
211.100(a)
Approval and review of
procedures
Written procedures are not [drafted, reviewed and approved
by the appropriate organizational units] [reviewed and
approved by the quality control unit]. Specifically, ***
4 11

Ref: WL: Piramal Critical Care Inc. (07-2013)

Ref: WL: Teva Parenteral Medicined Inc. (07/2009)

Ref: WL: Advanced Pharma Inc. (03-2014)

Ref: WL: Sandoz Inc. (06/2011)

Ref: WL: SCA Pharmaceutical LLC. (04/2014/)

Ref: WL: Hospira Inc. (08-2013)

Ref: WL: OSO Biopharmaceuticals Manufacturing LLC. (08-2013)

Ref: WL: Ameridose LLC. (09-2012)

Ref: WL: Morton Grover Pharmaceuticals Inc. (03-2014)

Ref: WL: Impax Laboratories Inc. (07-2014)

Ref: WL: Ohm Laboratories Inc. (08/2009)

Warning letter observations -2014 - 21 CFR 211.100(a)
Ref: WL: Hikma Farmaceutica, (Portugal) S.A. 10/21/14 (320-15-003)
Your firm failed to establish adequate written procedures for production and
process control designed to assure that the drug products you manufacture
have the identity, strength, quality, and purity they purport or are represented
to possess, and your firm’s quality control unit did not review and approve
those procedures, including any changes (21 CFR 211.100(a)).
Your firm failed to provide adequate challenge test set vials to qualify your operators
and Quality Assurance (QA) staff to perform visual inspection of your drug product.
Our investigators identified that 14 of (b)(4) vials used to qualify the operators for
visual inspection were marked on top of the stopper with a number or a dot that was
easily visible to the operator who was holding the vial during qualification. This
practice allowed the operator to know in advance which vials were to be rejected.

Ref: WL: Hospira Australia Pty Ltd. 9/26/14 (320-14-15)
Your firm failed to establish written procedures for production and process
control designed to assure that the drug products you manufacture have the
identity, strength, quality, and purity they purport or are represented to
possess (21 CFR 211.100(a)). For example,
The information related to the increase in levels of (b)(4) (refer to #1a above) raises
concern about the validation of your (b)(4) manufacturing process.
Your firm identified a correlation between the increase in the (b)(4) impurity
and (b)(4) exceeding (b)(4)%. However, this was not addressed in a subsequent
study to demonstrate that the process remains in a state of control.
Provide a comprehensive protocol for the revalidation of your process as it relates
to (b)(4) process (Filling Stage) in removing (b)(4) in the (b)(4).

Ref: WL: Ameriderm Laboratories, Ltd. 12/2/13 (14-NWJ-02)
Your firm failed to establish written procedures for production and process control designed
to assure that the drug products you manufacture have the identity, strength, quality, and
purity they purport or are represented to possess (21 CFR 211.100(a)).
For example, you have not validated the manufacturing processes for
AmeriWash, DermaFix, Instaclean, and PeriShield. Your firm has not identified the component
attributes (e.g., solubility and viscosity) and the process parameters (e.g., mixing time, blending
speed, and temperature) that are important to produce these four OTC drug products (i.e., topical
gels, creams, and ointments) with consistent quality.
Your firm does not have assurance that the manufacturing processes are adequately controlled to
consistently ensure the quality and safety of AmeriWash, DermaFix, Instaclean, and PeriShield.
In addition, your firm's batch records do not document all significant process steps and parameters
such as mixing times, blending speeds, bulk hold times, and product yields. It is imperative that you
have adequate records to monitor and demonstrate control of your processes and ensure that
specified requirements are reproducibly (as determined during initial process validation studies, and
thereafter) achieved.

Ref: WL: Jubilant HollisterStier General Partnership 2/20/13 (320-13-08)
Your firm failed to establish adequate written procedures for production and process control
designed to assure that the drug products you manufacture have the
identity, strength, quality, or purity they purport or are represented to possess (21 CFR 211.100
(a)).
For example, SOP 1179 Version 03, entitled “Inspection of Vials of (b)(4) Products,” and SOP 1086
Version 02, entitled “Visual Inspection of (b)(4) Products” are deficient in the following ways:
a. They include an acceptance rate for major vial defects of ≤ (b)(4)% and ≤ (b)(4)%
for (b)(4) and (b)(4)products, respectively, but do not provide for a corrective and preventive
action to be taken if the acceptance criterion is exceeded.
Continued ….

Ref: WL: Jubilant HollisterStier General Partnership 2/20/13 (320-13-08)
b. They do not provide for a second inspection or additional evaluation when the product fails to meet
its specification.
Our inspection documented that (b)(4) lots #(b)(4), #(b)(4), and #(b)(4) exceeded the acceptance
criteria, but that you released them for distribution with no additional evaluation (e.g., 100% inspection
or AQL inspection) to assure that the quality and purity of the entire lot was not compromised. Your
firm informed the investigator that, based on the procedure detailed in SOP 1179, your firm only
inspects lots once regardless of the number of defective vial rejection rate. As a result, you released
to the market (b)(4) Lots #(b)(4), #(b)(4), and #(b)(4)despite their (b)(4)%, (b)(4)%, and (b)(4)% major
defect rejection rates, respectively.
Your firm’s SOP for (b)(4) product visual inspection, SOP 1086 Version 02, entitled “Visual Inspection
of (b)(4)Injectable Products” is similarly deficient. It does not require corrective and preventive action if
the acceptance criterion is exceeded, nor does it provide for a second inspection or other appropriate
additional evaluation when the product fails to meet its specification. Despite a visual inspection
acceptance rate for major defects of ≤ (b)(4), you released (b)(4) Lots #(b)(4), #(b)(4), and
#(b)(4) with (b)(4)%, (b)(4)%, and (b)(4)% major defect rates, respectively. You did not conduct any
acceptance quality limit (AQL) inspection or a second 100% visual inspection.

Ref: WL: P.A. Benjamin Manufacturing Co., Ltd. 1/29/13 (320-13-07)
Your firm failed to establish adequate written procedures for production and process control
identity, strength, quality, and purity they purport or are represented to possess, and your
firm’s quality control unit did not review and approve those procedures, including any
changes (21 CFR 211.100(a)).
Specifically, your firm has not validated the manufacturing processes for the OTC drug
products, Diphenhydramine Elixir, Diphenhydramine Expectorant, and Infant Gripe Mix. In
addition, you reprocessed several batches of these products without approval by the Quality Unit and
without assessing the impact of the changes on the quality of the product.

Ref: WL: Kanebo Cosmetics Inc. 4/1/13 (320-13-14)
Your firm failed to establish adequate written procedures for production and process controls
identity, strength, quality, and/or purity they purport or are represented to possess (21 CFR
211.100(a)).
For example, the manufacturing processes for your (b)(4) OTC drug products intended for the U.S.
market are not validated.
In response to this letter, provide validation protocols with scientifically justified acceptance criteria
and results of the validation studies. If you have not completed your process validation, please
provide a schedule with milestones for its completion. Describe in-process controls your firm will
institute to ensure that your processes are performing as intended.

CFR part 211 Regulation - 21 CFR 211.100(b)
Subpart F--Production and Process Controls
• Sec. 211.100 Written procedures; deviations.
(b) Written production and process control procedures shall be followed in the execution of
the various production and process control functions and shall be documented at the time
of performance. Any deviation from the written procedures shall be recorded and justified.

483 citations related to 21 CFR 211.100(b)
Cite Id
Reference
Number
Short Description Long Description
Frequency
2014 2013
1358
21 CFR
211.100(b)
SOPs not followed /
documented
Written production and process control procedures are not
[followed in the execution of production and process control
functions] [documented at the time of performance]. Specifically,
***
43 59
3572
21 CFR
211.100(b)
Procedure Deviations
Recorded and Justified
Deviations from written production and process control
procedures are not [recorded] [justified]. Specifically, ***
19 25

Ref: 483 of APP Pharmaceuticals Inc (07/2011)

Ref: 483 of Novartis Consumer Health (02/2013)
Continued…

Ref: 483 of Novartis Consumer Health (02/2013)

Ref: WL: Ohm Laboratories Inc. (08/2009)

Warning letter observations -2013 - 21 CFR 211.100(b)
Ref: WL: Wockhardt Limited 11/25/13 (320-14-01)
Your firm failed to follow written procedures for production and process control designed to
assure that the drug products you manufacture have the identity, strength, quality, and purity
they purport or are represented to possess, and to document same at the time of performance
(21 CFR 211.100(b)).
At your Chikalthana site, our investigators observed poor documentation practices during in-process
testing. Specifically, an operator performed the in-process tablet (b)(4) testing for the (b)(4) mg tablet
batch #(b)(4)without the batch record or a manufacturing form to document the results
contemporaneously.
The FDA investigator was informed that the pre-test and post-test weight values are documented in
the batch record located in a separate manufacturing room rather than in the same room where the
actual weights are measured.

Warning letter observations -2013 - 21 CFR 211.100(b)
Ref: WL: Wockhardt Limited 11/25/13 (320-14-01)
…. Continued
Moreover, your operator stated that he records the two weights with (b)(4) significant figures
into the batch record from memory. Your investigation into this issue is inadequate because
it did not consider other in-process tests or whether the operator(s) have been involved in
the same poor documentation practices for others batches.
Additionally, the investigator noticed that the balance used in production was not level, which
can result in inaccurate weights. The investigator asked how long the balance had not been
level, and you indicated that you would investigate the matter and respond to the
investigator.

Other Guidance …

Comparison between US and EC GMP

EU Non-Compliance Reports
Firm Name Nature of non-compliance
Zhejiang Apeloa
Kangyu Bio-
Pharmaceutical Co.
Ltd., China; Nov 2014
The company failed to establish a procedure to identify and validate GMP-
relevant computerized systems in general.
VETPROM AD,
Bulgaria; Aug 2014
The procedure for cleaning validation is ineffective and does not include all
medicines (human and animal medicinal use);
Renown
Pharmaceuticals Pvt.
Ltd., Gujarat, India;
Aug 2014
Inappropriate validation of cleaning procedures.
Defects on deviation recording and investigation.

Health Canada – GMP
• Examples of observations from frequently cited sections of the Food and Drug
Regulations - Good Manufacturing Practices Inspections

pharmauptoday@gmail.comHow to avoid 21 CFR 211.160 observations ?

Procedures
Standard operating procedure (SOP)
• An authorized written procedure giving instructions for performing operations not
necessarily specific to a given product or material (e.g. equipment
operation, maintenance and cleaning; validation; cleaning of premises and
environmental control; sampling and inspection). Certain SOPs may be used to
supplement product-specific master and batch production documentation.
• An SOP is a set of instructions or steps someone follows to complete a job
safely, with no adverse impact on the environment (and which meets compliance
standards), and in a way that maximizes operational and production requirements.
Write SOPs for any processes an individual or group performs: unloading raw
materials, manufacturing products, shutting down an operation, repairing a faulty
electrical circuit, and thousands of other workplace activities.

Procedures
• These procedures describe the methods that will be used to implement and
perform the stated policies.
• The procedures define who should perform the specific tasks, when the task
should be done, and where the documentation will be made showing that task was
performed.
• The Procedure (Standard Operating Procedures) shall be reviewed periodically.
• SOPs should preferably be written in the laboratory close to the instrument, and
not in an office. It should be either written or thoroughly reviewed by the
instruments’ operators.
• SOPs should not be written to explain how procedures are supposed to work, but
how they work.

Reasons for having written procedures
• To provide individuals who perform operations with all the safety, health, environmental and operational information
required to perform a job properly
• To protect the health and safety of employees, and to protect the environment
• To ensure that operations are done consistently in order to maintain quality control of processes and products
• To ensure that processes continue and are completed on a prescribed schedule
• To ensure that no failures occur in manufacturing and related processes that would harm employees or anyone in
the surrounding community
• To ensure that approved procedures are followed in compliance with company and regulatory requirements
• To serve as a training document for teaching users about a process
• To serve as an historical record of the how, why and when of steps in a process for use when modifications are
made to that process and when a SOP must be revised
• To serve as an explanation of steps in a process that can be reviewed in incident investigations that seek to improve
safety practices and operating

Procedures
• This ensures that the information is adequate
and that the document invites rather than
discourages routine use.
• Content should cover:
• SOP unique number and revision number,
• Page number and total number of pages,
• for equipment testing: performance acceptance
criteria, recommended corrective actions, and a
template for continuous entries of test results and
corrective actions,
• printing history.

Flow Diagram for SOP preparation & implementation

Procedures
• Copies of SOPs for equipment should be located close to the instruments and
must be easily accessible by operators.
• Deviations from SOPs in a study must be authorized and significant changes in
established SOPs must be authorized in writing by management.
• Standard operating procedures should be drafted in a language understood in the
workplace.

Procedures
Have approved procedures in place for
• Equipment startup and operation
• Equipment set up and change over
• Product assembly
• Inventory tracking
• Material ordering
• Material receiving
• Maintenance procedures
• Material processing (e.g., mixing, batching)
• Quality control
• Quality Assurance
• Environment, Health & Safety
• Any business or process step that needs to be controlled

Deviation - Definition
• Departure from an approved instruction or established standard.
• There are many different contexts for use of the term “deviation”. No clear, sharply outlined
definition can be found in the various regulatory documents in the USA or the EU. The terms used
are not always the same either (for example, deviation, discrepancy, atypical
situation, nonconformity).
• Therefore, it is imperative for a company to define internally what is understood by the term
deviation, in order to avoid vagueness and possible misunderstandings concerning workflows and
responsibilities.
• In the narrower sense of the word deviations represent a failure to meet specifications (such as
parameter settings) in the production process, in-process specifications or production
requirements. In a broader sense, however, deviations from other procedures or instructions can
also be assigned to the deviation system.

Deviation Handling
• An efficient deviation handling system, should implement a mechanism to discriminate events
based on their relevance and to objectively categorize them, concentrating resources and efforts in
good quality investigations of the root causes of relevant deviations.
• A strong CAPA system requires this efficient deviation handling system which evaluates the event
according to the associated risk, categorizes it and acts accordingly in a timely manner, and
verifies the effectiveness of the actions taken.
• As a formal or informal tool, Quality Risk Management (QRM) has always been part of the analysis
process linked to the handling of events and deviations in pharmaceutical operations.
• Quality Risk Management was mainly designed to be used prospectively when manufacturing
operations are defined and validated. Therefore, potential deviations are identified and avoided by
implementing risk control measures and preventive actions.

Deviation Handling
• The application of risk management in dealing with deviations is not only practical but provides a
framework for a decision-making process based on a scientifically sound and objective
approach, while also enabling decisions to be confidently upheld before the regulatory authorities.
Under this approach, a sequence of steps may be identified when handling events and possible
deviations:
• Event Detection
• Decision Making Process / Deviation Categorization
• Deviation Treatment
• Root cause investigation
• CAPA

Decision Tree for Deviation
Classification
• Deviations should require a higher level of
analysis and documentation, and are usually
covered by a deviation handling procedure.
• At this point, a decision needs to be made to
categorize the deviation as Minor, Major or
Critical.

Flowchart for deviation
management

Area & Examples of deviations
Production process
• Manufacturing Formula
• Process parameters (e.g.
machine parameters)
• Process specifications
(e.g. target values in
production process or
yield limits)
• Testing instructions for in-
process controls (e.g.
using obsolete versions)
• In-process specifications
• Anomalies in the process
Machines, plants, equipme
nt, facilities,
and media (including
laboratory)
• Machine defects
• System failures
• Temperature, humidity, n
umber of particles or
pressure differences
outside of limits
• Deviations in
microbiological
monitoring
• Calibration results
outside of limits
• Failure to keep
calibration or
maintenance intervals
Regulations
• SOPs
Quality control
• Results out of
specification (OOS)
• Results out of trend
(OOT)
• Results close to
specification limit
• Using expire reference
standards

Requirements for handling deviations
• Complete record of the deviation
• Complete investigation into root causes
• Risk assessment of the deviation for the current batch
• Expanding the search to other, possibly affected batches or products
• Specifying actions for the affected batch
• Specifying actions to prevent recurrence (corrective actions)
• Assessing the risk from intended actions
• Defining tests for effectiveness to assess suitability of the actions
• Implementing the actions
• Testing effectiveness of the actions
• Periodic review of the system effectiveness

Thank You
The module Consult Yourself.... “Know Regulation - No Observation” deals with most common (top 20)
basic CFR regulations having frequent violations and previous observations for better understanding.
The module will be continued with # 4 21 CFR 211.165
(Subpart I--Laboratory Controls, Testing and release for distribution)
For “Pharma Uptoday” free daily newsletter write a mail to pharmauptoday@gmail.com
for other Pharma Uptoday presentations & Monthly Magazines browse:
http://www.slideshare.net/skvemula

Top 20 observation series # 5 21 CFR 211.100

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (20)

Similar to Top 20 observation series # 5 21 CFR 211.100

Similar to Top 20 observation series # 5 21 CFR 211.100 (20)

More from Sathish Vemula

More from Sathish Vemula (16)

Recently uploaded

Recently uploaded (20)

Top 20 observation series # 5 21 CFR 211.100