This document discusses various quality management systems and standards used in the pharmaceutical industry. It covers topics like knowledge management, quality by design approach, quality metrics, operational excellence, quality management review, quality tools like control charts and histograms, OHSAS guidelines, NABL certification and accreditation, differences between certification and accreditation, and fields of testing covered by NABL.

1. PRESENTED BY-
POONAM R. PARDHI
M.PHARM (QA)
S.G.M COLLEGE OF PHARMACY,
MAHAGAON
GUIDED BY-
DR.RAVINDRA B. KUMBHAR
(ASST. PROFESSOR)
S.G.M COLLEGE OF PHARMACY,
MAHAGAON

2. Contents:-
1. KNOWLEDGE MANAGEMENT
2. QUALITY METRICS
3. OPERATIONAL EXCELLENCE AND QUALITY MANAGEMENT REVIEW
4. OSHAS GUIDELINES
5. NABL CERTIFICATION AND ACCREDITATION
6. CFR-21 PART 11
7. WHO-GMP REQUIREMENT

3. KNOWLEDGE MANAGMENT
• Knowledge Management is a systematic approach to acquiring, analysing, storing,
and disseminating information related to products, manufacturing processes and
components.
• Sources of knowledge include
1) prior knowledge
2)pharmaceutical development studies
3)technology transfer activities
4)process validation studies over the product lifecycle
5)manufacturing experience
6)innovation
7)continual improvement
8)change management activities

4. WHAT IS KNOWLEDGE MANAGEMENT?
• Knowledge Management (KM) is a set of enabling capabilities and associated behaviors;
that supports how knowledge is acquired, analyzed, stored, disseminated and applied; so
that knowledge will flow, grow and evolve over time.
acquire
analyze
store
disseminate
apply

5. QbD Approach
• Quality by design allow for a systemic approach to drug development
that is intended to improve quality by using analytical and risk
management methodologies for the Design development and
manufacturing of new medicament.
Advantages :-
• Quality built into product and process by design are based on scientific
understanding.
• Knowledge rich submission (showing product knowledge and process
understanding)
• Flexible process allowing continuous improvement.

6. TARGET PRODUCT PROFILE
CQAs (CRITICAL QUALTY ATTRIBUTES)
RISK ASSESSMENT
DESIGN SPACE
CONTROL STRATEGY
LIFE CYCLE MANGEMENT

7. • TARGET PRODUCT PROFILE- Outlines the desried characterictics of a target product that is aimed
at particular disease or diseases.
• CQAs- Critical quality attributes are physical, chemical, biological, microbiological that should be
within an appropriate limit or range or Distribution to ensure the desired product quality.
• RISK ASSESSMENT- It is a systemic process for identification, assessment, control, communication
and review of risk to quality system process.
• DESIGN SPACE- scientific concept used in pharma/biopharma industry to support and assure product
quality.
• CONTROL STRATEGY- 1)Build company culture that emphasize quality improvement
2)develop a detailed quality inspection program.
3)Ensure that equipment are maintained regularly
4) Schedule periodic audit.
• LIFE CYCLE MANAGEMENT- Process of managing a product’s lifecycle from inception through
design and manufacturing to sales services and eventually retirement.

8. CASE STUDY
• A detailed study of a person, group, or situation over a period of time.
• In a case study nearly every aspect of the subjects life and history is analysed to seek pattern and
cause of behaviour.
• It understands business process for development, technology transfer and manufacturing.
(What knowledge is needed, what is created and how is it used?
• Create a knowledge map to understand knowledge flow.
(How is knowledge acquired, analyzed, stored, disseminated and applied?
• Identify priority gaps and opportunities
• Develop and apply approaches to ensure, standardize and optimize knowledge flow.
• Many well established approaches exist to help enable knowledge to flow-
1)Communities & Networks 2)Federated Search
3)Content management 4)Transfer of best practices
5)Collaboration capabilities 6)Knowledge harvesting
7)Expertise location
• This approaches can be replicated to similar knowledge flow gaps and oppourtunities.

9. QUALITY METRICS
• METRICS= A system or standard of measurement.
• Quality metrics are essential component of effective Quality Management Plan in Pharmaceuticals.
Usefullness of Quality metrics in Pharma Industry
• The major role is to drive continuous improvement efforts and monitor quality system and process
when drug is getting manufactured.
• Quality metrics are systematatic and refined representation of all the quality manufacturing
operations.

10. • Quality metrics are helpful in forming the scheduling of risk based drug manufacturing
• These are useful in improving the ability of manufacturer to mitigate shortage of drugs in future.
• Encourage the innovation of total quality management system
• Helps in ensuring all patients receive high quality,effective and safe medication
• Help in solving quality issue
• It enable the manufacturer to make timely and sound decision,set strategic vision ,mission and plans
• However the manufacturer should –
1) ensure electronic reporting and sharing of data
2)react quickly as possible to any problem that might arise during manufacturing process
3)develop procedure that should help them to maintain quality metric system

11. OPERATIONAL EXCELLENCE
• Operational excellence is a broader program of improving and sustaining business
performance in which quality management is embedded.
• Operational excellence has become an important approach in many of the firms and it
aims to rise the keenness by growing the organizational productivity in area such as
quicker time to market,reduced cost,improved quality,and reducedlead time for supplying
materials,which can have a key impact on companys revenue.

12. QUALITY MANAGEMENT REVIEW
• The Quality Management Review is the apex of the Quality System and is used to assess
the progress and continual improvement of that System.
• Top Management meet to assess the performance of the system against the organisations
goals and objectives and to decide on what needs to be done to further improve the system

13. • Just as every organization undertakes an annual ritual of financial review, forecasting,
planningand budgeting, a similar approach is specified in the ISO 9001:2008 standard for
quality management.
• In the ISO 9001 standard, this process is referred to as a Management Review.
• Typically, such reviews are held as regularly scheduled events within an organization, with
top management to review the performance of its quality management system against
organizational goals and objectives, and other criteria as specified within the standard.
• Specifically, as stated within the ISO 9001 standard, the purpose of a management review is
to review the Quality Management System to ensure is continuing adequacy, suitability and
effectiveness.
• This should include an evaluation of the performance of the system based on existing data,
and should address any decisions or actions necessary to improve the program and its
related processes.
• Records of these reviews should be maintained in accordance with documented record
control procedures.
• These records should include, as a minimum, the date of the review, participants in the
review, criteria by which the system is measured, strengths and weaknesses of the system,
and any decisions or actions that are required.

14. QUALITY MANAGEMENT TOOLS
• Check sheet:-
The check sheet is a form (document) used to collect data in real time at the location where
the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is sometimes called a tally sheet.
The defining characteristic of a check sheet is that data are recorded by making marks
("checks") on it.
A typical check sheet is divided into regions, and marks made in different regions have
different significance. Data are read by observing the location and number of marks on the
sheet.

15. • Control chart:-
Control charts, also known as Shewhart charts (after Walter A. Shewhart) or process-behavior charts,
in statistical process control are tools used to determine if a manufacturing or business process is in
a state of statistical control.
If analysis of the control chart indicates that the process is currently under control (ie.. is stable, then
no corrections or changes to process control parameters are needed or desired.
In addition, data from the process can be used to predict the future performance of the process.
If the chart indicates that the monitored process is not in control, analysis of the chart can help
determine the sources of variation.
The control chart is one of the basic tools of quality control used for time-series data, though they can
be used for data that have logical comparability.

16. • Pareto chart:-
A Pareto chart, named after Vilfredo Pareto, is a type of chart that contains both bars and a line
graph, where individual values are represented in descending order by bars, and the cumulative total
is represented by the line.
The purpose of the Pareto chart is to highlight the most important among a set of factors.
In quality control, it often represents the most common sources of defects, the highest occurring type
of defect, or the most frequent reasons for customer complaints, and so on.

17. • Ishikawa diagram:-
Also called fishbone diagrams, cause-and-effect diagrams, or Fishikawa) are casual diagrams
created by Kaoru Ishikawa (1968) that show the causes of a specific event.
Common uses of the Ishikawa diagram are product design and quality defect prevention, to
identify potential factors causing an overall effect.
Each cause or reason for imperfection is a source of variation. Causes are usually grouped
into major categories to identify these sources of variation.

18. • Histogram diagram:-
A histogram is a graphical representation of the distribution of data.
It is an estimate of the probability distribution of a continuous variable (quantitative variable)
and was first introduced by Karl Pearson.
A histogram may also be normalized displaying relative frequencies.

19. What is OHSAS 18001 ?
• Stands for Occupational Health & Safety Assessment Series.
• OHSAS 18001 is recognized globally as the international management system standard that
specifies requirements for an OH&S MS(Occupational Health and Safety Management
System) to enable an organization to control its OH&S risks & improve its OH&S
performances.
• It allows organizations to integrate quality, environmental and occupational health and safety
management systems throughout its operations.
OHSAS GUIDELINES

20. ELEMENTS OF OHSAS 18001
• Developing an OH&S Policy
• Hazard Identification & Risk Assessment
• Identifying Legal Requirements
• Setting OH&S Objectives
• Establishing an OH&S Management System
• Training Employees
• Implementing OH&S Control Measures
• Emergency Planning
• Document and Record Control
• Corrective and Preventative Action
• Management Involvement and Management Review
• Steps to OHSAS 18001 Certification

21. PRINCIPLES OF OHSAS 18001
OHSAS 18001 is based on several principles which includes-
• Leadership Involvement - The top management of theorganization must be actively
engaged in the management system.
• Risk Management - Implementation of an OH&S management system is driven by the
risk management needs of the organization - the hazards and risks identified and the
controls that are determinedto be necessary to prevent injuries and ill health
• Commitment to Compliance - Societal interests, as reflected in the laws and
regulations promulgated, must be addressed
• Worker Participation - Workers, as the primary stakeholders of an occupational health
and safety management system, have the right tobe involved in management system
processes; and
• Performance Monitoring & Improvement – Continua limprovement, a management
system mantra, cannot be achieved unless processes are in place to measure
performance.

22. BENEFITS OF OHSAS IMPLEMENTATION
• Implementing an OH&S MS motivates staff as it shows commitment to their welfare and
employees then can feel greater commitment to the organization.
• The reduction in injury to workers is of benefit to both employees and employers.
• Cost savings can be made through reduced business interruptions and absenteeism and
greater motivation.
• Customers take confidence when seeing organizations managing occupational health and
safety as they are more confident that there will be no business interruptions and regulatory
action against their supplier.
• Reduction in insurance premiums can be obtained by improved risk management and
improved performance.

23. STEPS TO OHSAS IMPLEMENTATION
The process for establishing an OHSAS 18001 management system is essentially the same
as the process used for implementing an ISO 14001 system which are as follows:
• Preliminary review of existing programs and systems
• Identification of hazards and applicable laws and regulations
• Developing new procedures
• Training personnel programes
• Implementing new programs such as internal audit and management review
• Seeking certification of the OHSAS program

24. OH&S POLICY
Top management shall define and authorize the organization's OH&S policy and ensure that
within the defined scope of its OH&S management system it:
a) includes a commitment to prevention of injury and ill health and continual improvement in
OH&S management and OH&S performance;
b) includes a commitment to at least comply with applicable legal requirements and with other
requirements to which the organization subscribes that relate to its OH&S hazards
c) provides the framework for setting and reviewing OH&S objectives
d) is documented, implemented and maintained
e) is communicated to all persons working under the control of the organization with the intent
that they are made aware of their individual OH&S obligations
f) is reviewed periodically to ensure that it remains relevant and appropriate to the
organization.

25. NABL CERTIFICATION AND ACCREDITATION
• National Accreditation Board for testing and Calibration Laboratories (NABL)
is an autonomous body under the aegis of Department of Science &
Technology, Government of India, and is registered under the societies act.
• NABL has been established with the objective to provide Government,
Industry and Society in general with a scheme for third party assessment of
the quality and technical competence of testing and calibration laboratories
• Government of India has authorized NABL as the sole accreditation body for
testing and Calibrating laboratories
• These services are offered in non-discriminative manner and are accessible
to all testing and calibration laboratories in INDIA and abroad, regardless to
their ownership, legal status, size and degree of independence.

26. DIFFERENCE BETWEEN ACCREDITATION AND CERTIFICATION
CERTIFICATION ACCREDITATION
It is a comprehensive evaluation of a
process, system, product or event typically
measured against some existing norms or
standards.
It does not make any statement about the
technical competence of the laboratory.
eg:- ISO 9001:2005 certification
(organisation follows the guidelines of the
ISO 9001 standard. Fulfills its own
requirements. Meets customer
requirements and statutory and
regulatory requirements. Maintains
documentation)
It is a formal declaration by a neutral third
party that the certification program is
administered in a way that meets the
relevant norms and standards of certification
program.
Eg:- ISO 17025 (specifies requirements for
the competency of the entity to carry out
tests and/or calibrations, including
sampling.)

27. LABORATORY ACCREDITATION:-
• Laboratory accreditation is a procedure by which an authoritative body gives formal
recognition of technical competence for specific tests/ measurements, based on
third party assessment and following international standards.
• In order for a laboratory to become accredited it must not only prove it has a quality
system that meets the specific requirements, it must also prove it is
technically competent, i.e. meets the claimed measurement accuracies , for the testing or
calibrations listed on its Scope of Accreditation.

28. CONCEPT OF LABORATORY ACCREDITATION:-
• The concept of laboratory accreditation was developed to provide a means for third party
certification of the competence of laboratories to perform specific type of testing and
calibration.
• It provide formal recognition of competent laboratories thus providing a ready means for
customer to find reliable testing and calibration services in order to meet their demands.
• It enhance customer confidence in accepting testing/calibration report issued by
accrediated laboratories.
BENEFITS OF ACCREDITATION:-
• increased confidence in Testing/ Calibration Reports issued by the testing, calibration
and medical testing laboratories which emphasise on accuracy and reliable results.
• Customers can search and identify the laboratories accredited by NABL for their specific
requirements from the NABL website or Directory of Accredited Laboratories

29. Patients
NABH standards facilitate patient safety and reduction in errors
• Improved quality of care and importance to patient rights results in a greater patient
satisfaction rate
• Accreditation helps improve the confidence of the community towards the services
provided by the hospital
Staff
• Results in greater staff satisfaction as it provides an opportunity for continuous learning,
good working environment and ownership of clinical processes
• It also helps recruitment activities as the staff prefers to work with an accredited
organization over a non- accredited organization
• It ensures staff efficiency, accountability and adherence to Standard Operating Procedures
• Accreditation bodies provide continuous support and training to accredited organization

30. Marketing
• An accreditation status provides marketing advantage in a competitive health care
marketplace and improves the ability to secure new business
• It provides an opportunity for the hospital to benchmark its services with the best and in
turn helps promote footfalls along with medical tourism
Hospital
• In addition to the above, an accreditation helps the organization streamline its processes
and ensure adherence to it
• It also provides a framework for setting up quality improvement plans
• Helps in risk management
• The quality of healthcare imparted to patients in several hospitals in India fall short of
standards of care and healing. One can only hope that a combination of realization by
these hospitals to improve and the passing of a law to make quality accreditation
mandatory will eventually lead to quality healthcare in its truest sense.

31. FIELDS OF TESTING AND CALIBRATION COVERED BY NABL
Testing laboratories Calibration laboratories Medical laboratories
Biological Electro-technical Clinical biochemistry
Chemical Mechanical Clinical pathology
Electrical Thermal & optical Haematology &
immunohaematology
Mechanical radiological Microbiology & serology
Photometry Histopathology
Radiological Cytopathology
Thermal Genetics
Electronics

32. BENEFITS OF ACCREDITATION
• Potential increase in business due to enhanced customer confidence and satisfaction.
• Savings in terms of time and money due to reduction or elimination of the need for re-
testing of products
• Better control of laboratory operations and feedback to laboratories as to whether they
have sound Quality Assurance System and are technically competent.
• Makes the lab conscious of quality.
• Independent certification of lab competence.
• Increases client confidence.
• Builds staff morale.
• Improves lab performance.
• Improves business prospects.

33. PREPARATION REQUIRED BY LABORATORY FOR ACCREDITATION
• Laboratory management should first decide about getting accreditation for its laboratory
from NABL
• It is important for a laboratory to make a definite plan of action for obtaining accreditation
and nominate a responsible person to coordinate all activities related to seeking
accreditation.
• The person should familiar with laboratory’s existing quality system.
• Procure all NABL document fron NABL secretariat.
• It must be remembered that quality manual is policy document which has to be
supplemented by a set of other document like procedural manual, work instructions, etc.
to align quality system in accordance with NABL criteria.
• Relevant requirement for NABL accreditation should be discussed amongst concerned
staff of the laboratory
• It enables them to understand the weaknesses and strengths
• Quality manager must conduct internal audit and take corrective actions before applying
for accreditation.

34. ACCREDITATION PROCESS
Application for accreditation (by laboratory)
Acknowledment and scrutiny of application (by NABL
secretrariat)
Adequacy of quality manual (by lead assessor)
Pre-assessment of laboratory (by lead assessor)
Final assessment of laboratory (by assessment team)
Scrutiny of assessment report (by NABL secretariat)
Recommendation for accreditation (by accreditation
committee)
Approval for accreditation (by chairman NABL)
Issue of accreditation certificate (by NABL secretariat)
Feedback
To
Laboratory
And
Necessary corrective
Action by
Laboratory.

35. CFR-21 PART 11
Introduction to 21 CFR Part 11
• 21 CFR Part II is an important section of the Code of Federal Regulations
• 21 CFR Part II deals with rules for electronic records and electronic signatures as set out
by the FDA
• It needs to be understood that each title and part of the CFR denotes a certain industry or
activity
• In this instance, 21 CFR is the FDA title for PHARMA and medical devices, while Part II
relates to a specific activity, namely electronic signatures and record Under the board of
pharmaceuticals and medical devices, a host of activities are included.
• In 1999, computerized systems that are used in clinical trials came under 21 CFR Part II

36. What is an electronic record ?
FDA guidance defines (Electronic Records; Electronic Signatures (Scope and- application)
defines electronic record as :- Records that are required to be maintained under predicate rule
requirements and that are maintained in electronic format in place of paper format.
Records that are required to be maintained under predicate rules, that are maintained in
electronic format in addition to paper format, and that are relied on to perform regulated
activities.
Electronic signatures that are intended to be the equivalent of handwritten signatures, initials,
and other general signings required by predicate rules.

37. 21 CFR PART 11- 10 STEPS TO COMPLIANCE
• Fully documented and validated systems including change control
• Ability to generate accurate and complete copies of records for inspection and review by
the system
• Ability to protect and easily retrieve records through their retention period
• Ability to discern changes to records through the use of audit trails
• Proper security controls (authentication, user rights, Access Management)
• Trained and qualified individuals
• SOPs in use in place
• Encryption for open systems
• e-Signature components and controls (i.e. System could Identify e-Signature)
• Linking of electronic signatures to records

38. Requirement 1- System Documentation / validation
A formal process to ensure that:-
• systems consistently operate as they were intended
• user, business and regulatory system requirements are met
• information is secure and properly managed by the system
• procedures and processes are in place for the use management of the system
Requirement 2- Ability to generate accura complete copies of records
• Indexing and search system to be able to easily find records in the case of inspection
• Ability to print records or to provide an 'Inspector' view to final records and associated audit trail /
e-Signature information
• Document lifecycle status should be clear i.e. Final Record? Version?
• You should be able to produce copies of records in a common portable format (PDF, XML)

39. Requirement 3- Protect and easily retrieve records through their retention period
• Ensure that a full system backup is in place (preferably with an offsite copy in case of disaster)
• Perform regular backup restoration tests
• Ensure system is part of the disaster recovery plan
• Store final records in public portable format (PDF, XML) if possible to ensure system independence
• Apply retention policies in the system in line with records retention SOP
Requirement 4 - Ability to discern changes to records through the use of audit trails
• Audit trail should be applied to all records in the system (documents,metadata, signatures)
• Audit trail elements include:- 1.Username 2.Record Identifier 3.Type of audit entry (new, modify,
delete, view etc.) 4.Date/time stamp (with time zone) 5.Old/New value (can be in the document or in
version history/audit trail)
• If working with a 3rd party, they should provide the audit trail with the electronic records
• Audit trails should be computer generated and non-modifiable

40. Requirement 5 - Proper security controls
• Each user must have a unique logon and password to access the system.
• Passwords should be changed periodically
• The system should have the ability to detect security breaches
• The system should have a granular security system based on user security profiles which can be
applied up to the document level
• The system should be able to enforce sequencing of events based on document status
• The system should ensure that final records are read only
Requirement 6- Trained and Qualified Individual
• There should be clear job descriptions for all roles required to develop, install, validate, maintain
and use the system
• There should be formal training on both the SOPs that govern the system and the
administration/use of the system
• Job descriptions should clearly describe the qualifications required for each role
• A training matrix should clearly indicate which SOPs should betrained on for each role
• CVs and training records should be maintained on file

41. Requirement 7 – SOPS
There should be formal SOPs in place for:
• Software development and validation System change control
• Physical and logical security / data protection System maintenance and administration
• Disaster recovery and business continuity
• Use of electronic and digital signatures
• Records management (including records retention and archiving)System management
• Any other regulated processes managed with the system....
Requirement 8- encryption
If the system is hosted or being used by individuals outside of the organization (and therefore
transiting over the internet) then it may be considered an open system
Definition of an open system: environment in which system access is not controlled by persons who
are responsible for the content of electronic records that are on the system
Use of encryption such as SSL or VPN can be used to ensure confidentiality
Use of digital signatures can also help to show integrity and authenticity

42. Requirement 9- e-Signature components an controls General Requirements
• E-Signature should be unique to an individual
• There should be at least two elements of identification used to sign
• Signers must be trained on the use of e-Signatures and sign a non-repudiation form which clearly
identifies them
• E-Signatures should become invalid if a record changes after being signed
• Should be designed to require the collaboration of 2+ individuals to use someone else's e-Signature
• Implement a password policy to periodically require that passwords are changed (90 days...)
• Implement a loss management procedure in your SOP on e-Signatures/logical security
• Don't forget to send the letter of certification...

43. Components of e-signature

44. Requirement 10 - Signature linking to records Electronic signature linking
• Just reproducing the signature information on the record is not sufficient
• Database entries must be maintained as electronic records i.e. audit trail etc.
• System must be maintained over time so as to maintain the ability to discern changes to records
and link to records
• Impossible to know if a record has changed if record lives outside of the system

45. WHO-GMP REQUIREMENT
What is GMP?
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug
substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Why GMP is important?
A poor quality medicine may contain toxic substances that have been unintentionally added.. A
medicine that contains little or none of the claimed ingredient will not have the intended therapeutic
effect.
OBJECTIVE:-
Guarantee high quality productsto consumer.
Delivering products free of all possible contamination

46. Principles of GMP
• Design and construct the facilities and equipments properly
• Follow written procedures and Instructions
• Document work.
• Validate work
• Monitor facilities and equipment
• Write step by step operating procedures and work on instructions
• Protect against contamination
• Control components and product related processes
• Conduct planned and periodic audits

47. GENERAL REQUIREMENTS
• Avoid risks and possibilities of mix-up at all stages of Mfg, labeling Pkg and testing
• AHUs, comfort of the personnel working and regular monitoring of temp & humidity,
Particle Count, DOP testing etc.
• Proper drainage system which prevents backflow. Avoid open channels and if provided
must be able to clean and disinfect.

48. GMP Categories
Samples- Retain samples of each lot of raw material and finished product for specified period
of time
Stability- Establish the length of time in which the product meets all specification
Monitor the drug for this period of time
Sterile Products- Packaged in separate enclosed area by trained personnel using method to
ensure sterility
Personnel- Appropriate education, training and experience
Sufficient number of people
Receive GMP training
Sanitation- Program to prevent contamination
Limit the sources and types of contamination
Cleaning procedures for facilities & equipment
- Pest control.
- Environmental monitoring

49. Raw Material, Packaging Material and Finished Product Testing
• each lot or batch of raw material is tested
• Samples of incoming materials are collected and tested before use
• Approved test methods and specifications are used
• Results must conform to specifications for release for use or sale
• Transportation and storage records
Manufacturing Control
• Written procedures are established and followed
Master formulae, manufacturing order and packaging order .
• Critical processes are validated
• 2nd person verification of activities
• Self-Inspection Programmed

50. Sale
No distributor ... and no importer shall sell a drug unless it has been fabricated, packaged/labeled,
tested, and stored.
Premises & Equipment
Permits effective cleaning
Prevents contamination
Orderly conditions.
Good state of repair
Records
Document all GMP activities
Use Good Documentation Practices (GDP)
Records must be readily available
Good Documentation Practices.
Documentation must be-
permanent (black or blue ink) legible, clear, concise,accurate,Timely complete

51. Quality Control Department
Quality Control Responsibilities-
Testing of bulk components prior to use by production
Testing of finished product prior to release for sale
Stability program
Review batch records, labels
Release product, based on QC test results
Training, auditing
Customer complaints