GxP and cGxP in Bio/Pharmaceutical Industry

GxP and cGxP in Bio/Pharmaceutical
Industry
Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D
Department of Pharmaceutics
KLE University College of Pharmacy
BELGAUM – 590010, Karnataka, India
E-mail: bknanjwade@yahoo.co.in
Cell No: 00919742431000
28 March 2011 1Department of Pharmaceutics

GxP
• The bio/pharmaceutical industry has created its own
language and GxP is one of many acronyms that we all
tend to use.
• While this may seem “elementary” to some of you,
many people may not know what this means.
• G = Good
x (variable replaced with Manufacturing, Clinical,
Laboratory, Storage, Distribution and Review)
P = Practice
2Department of Pharmaceutics28 March 2011

GxP
• As you can see, GxP is used as short-hand form for
referring to the regulations established by the United States
Food and Drug Administration which are published in the
Code of Federal Regulations.
• Sometimes people refer to the “GCPs” which specifically
regards the rules that govern clinical trials vs. product
manufacturing (GMPs) or laboratory regulations (GLPs).
• Together, these are known collectively as the “predicate
rules” that govern a wide spectrum of regulatory obligations
across this diverse industry.

GxP
• GxP is also where citations emanate from (typically) as
regards FDA inspections.
• When a regulation is cited, the title tells you where it is
published.
For example: 21 CFR 312.2
Means:
21 = Title 21
CFR = Code of Federal Regulations
312.2 (312 = part and 2 =section)

Lifecycle Requirements

GxP
• “GxP” is a collective term for the Good Practice quality
guidelines and regulations used in many fields,
encompassing such internationally-recognized standards
as GMP, GCP, GLP, GSP, GDP and GRP.
• GxP guidelines are designed to ensure that products are
safe, meet their intended use and, in regulated industries
such as drugs, food, medical devices and cosmetics,
adhere to quality processes during manufacturing, control,
storage and distribution.

GxP
• GxP is a general term for Good Practice quality
guidelines and regulations. These guidelines are used
in many fields, including the pharmaceutical and food
industries.
• The titles of these good practice guidelines usually
begin with "Good" and end in "Practice", with the
specific practice descriptor in between.
• GxP represents the abbreviations of these titles, where
x (a common symbol for a variable) represents the
specific descriptor.

Core GXP Information

Regional Harmonization Initiatives

GxP

List of GxP’s in Pharmaceuticals
1. GMP – (Good manufacturing Practice)
2. GCP – (Good Clinical Practice)
3. GLP – (Good Laboratory Practice)
4. GSP – (Good Storage Practice)
5. GDP – (Good Distribution practice)
6. GRP – (Good Review Practice)

Purpose of GxP
• The purpose of the GxP quality guidelines is to ensure a
product is safe and meets its intended use.
• GxP guides quality manufacture in regulated industries
including food, drugs, medical devices and cosmetics.
The most central aspects of GxP are:
1. Traceability: the ability to reconstruct the development
history of a drug or medical device.
2. Accountability: the ability to resolve who has contributed
what to the development and when. 12Department of Pharmaceutics28 March 2011

Regulators

GMP – (Good Manufacturing Practice)
28 March 2011 Department of Pharmaceutics 14

What is GMP ?
• GMP is that part of Quality assurance which ensures that
the products are consistently manufactured and controlled
to the Quality standards appropriate to their intended use
• A set of principles and procedures which, when followed by
manufacturers for therapeutic goods, helps ensure that the
products manufacture will have the required quality.

Good Manufacturing Practices
• A basic tenet of GMP is that quality cannot be tested into a
batch of product but must be built into each batch of
product during all stages of the manufacturing process.
• It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product.
- Some of the main risks are unexpected contamination of products, causing damage to
health or even death
- In correct labels on containers, which could mean that patient receive the wrong
medicine.
- Insufficient or too much active ingredient, resulting in ineffective treatment or adverse
effects.

GMP
QC
GMP
QA

GMP
• GMP is the magic key that opens the door of
the Quality
• In matter of GMP, swim with the current and
in matter of Quality stand like a rock!

GMP
GMP
Is that part of Quality
Assurance aimed at
ensuring that products are
consistently manufactured
to a quality appropriate to
their intended use

GMP guidelines
• GMP as per Schedule “M”
• GMP as per WHO
• GMP as per MCA now known as MHRA
• GMP as per TGA
• GMP as per US FDA
• GMP as per ICH guidelines

GMP guidance documents
• EU Good Manufacturing Practice (GMP)
Guidelines, Volume 4 of “The rules governing
medicinal products in the European Union”
• US FDA current Good Manufacturing Practice
(cGMP) for finished pharmaceuticals, 21 CFR, 210
and 211
• WHO Good Manufacturing Practices for
pharmaceutical products, Annex 4 to WHO
Technical Report Series, No. 908, 2003

GMP
• GMP in solid dosage forms
• GMP in semisolid dosage forms
• GMP in Liquid orals
• GMP in Parenterals Production
• GMP in Ayurvedic medicines
• GMP in Bio technological products
• GMP in Nutraceuticals and cosmeceuticals

API Manufacturing Process

Secondary Manufacturing Dosage
Forms

Secondary Manufacturing Process -
Tablets

Secondary Manufacturing Process – Sterile
parenteral for injection

Packaging

Biotechnology Manufacturing Process

Ten Principles of GMP
1. Design and construct the facilities and equipments
properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on
instructions
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits

Beyond GMP
• Reduce pollution - Zero discharge
• Adaptation of environment friendly methods
• Consideration for better and healthier life tomorrow
• Consideration of ethics in life
• One should begin with end in mind otherwise it will be the
beginning of the end

Cost of effective GMP
• In fact Cost benefits – positive cost benefits of GMP/QA
• Good plant lay out, Smooth work flows, Efficient
documentation systems, well controlled process, good
stores lay outs and stores records- These are Good
manufacturing practices
• Reduction in work in process and inventory holding costs
• Avoidance of cost of Quality failure ( cost of waste, of
rework, of recall, of consumer compensation and of loss of
company reputation28 March 2011 Department of Pharmaceutics 33

Cost / Benefit analysis
• GMP is not an “On-cost”.
• It is not even “Just free”
• It is a contribution to profit
• Good manufacturing Practice is also Good
management Practice leading to Good
Manufacturing Profit
• GMP is central and basic and has cost benefits
( not to be considered as extrinsic or imposed
upon manufacturing activities)

Cost / benefit analysis
• Cost of quality = Cost of A – Cost of B- Payback from C = Profit
A B C
Staff Scrap Improved morale
Training Rework Motivation
Systems Complaints Faster throughput
Documentation Chaos Higher productivity
Equipment Lost sales Increased sales
Maintenance Recalls lower inventory
Calibration Closedown
Sampling
Testing
In process control
Validation
Auditing

GCP – (Good Clinical Practice)

What It Is GCP
• An international ethical & scientific quality standard for
designing, conducting, recording & reporting human clinical
studies
– EU
– Japan
– US
• Applies to registration studies that may have an impact on
safety & welfare of human subjects

GCP Participating Parties
• IRB/Ethics Committee
• Investigators
• Sponsor
• Regulatory Authorities

GCP Key Documents
• Investigator Brochure
• Study Protocol
• Informed Consent Document

GCP Principles
1. Studies in accordance with Declaration of Helsinki;
consistent with GCP & applicable regulatory
requirements
2. Studies initiated & continued only if anticipated
benefits outweigh risks
3. Rights, safety & welfare of human subjects take
priority over interests of science & society
4. Available non-clinical & clinical info on product
adequate to support study

GCP Principles
5. Studies scientifically sound; described in clear,
detailed protocol
6. Study in compliance with IRB/EC approved protocol
7. Medical care given to subjects is the responsibility of
qualified medical professional(s)
8. Individuals conducting studies qualified by education,
training & experience
9. Freely given informed consent obtained from every
subject prior to study participation

GCP Principles
10. Study information recorded, handled & stored to
allow accurate reporting, interpretation & verification
11. Confidentiality of subject records protected in
accordance with applicable regulatory requirements
12. Investigational products manufactured, handled &
stored in accordance with GCP & used in accordance
with approved protocol
13. Systems/procedures implemented to assure quality
of study

IRB/EC Roles & Responsibilities
To safeguard study subjects’ rights & welfare by:
• Evaluation/disposition of study proposal
• Evaluation of proposed subject consent materials
• Evaluation of emergency use consent methodology
• Evaluation of investigator qualifications
• Ongoing review of study progress (at least yearly)
• Evaluation of proposed subject compensation plans

IRB/EC Composition & Operations
• Membership has qualifications & experience to evaluate
science, medical aspects & ethics of proposed study
– ≥ 5 members
– ≥ 1 member whose primary interest in nonscientific
– ≥ 1 member independent of institution or study site
• Written SOPs & records
• Decisions rendered at announced meetings with quorum in
attendance

IRB/EC Composition & Operations
• Only members participating in review should
vote
• Investigator may provide info on study, but
should not be involved in review or vote
• Nonmembers with expertise in special areas
may be invited to assist with review (but cannot
vote)

IRB/EC Procedures
• Document group membership & qualifications
• Schedule meetings & notify members
• Conduct initial & ongoing review of studies
• Determine ongoing review frequency
• Provide expedited review of minor study changes, in
accordance with regulatory requirements
• Specify that no subject should be enrolled in study
prior to IRB/EC approval

IRB/EC Procedures
• Specify that no deviations from protocol should be initiated
without prior IRB/EC approval
– Emergency situations require immediate notification of IRB/EC after the
fact
• Specify that Investigator should promptly report:
– Protocol deviations
– Changes increasing subject risk or study procedures
– Serious and unexpected adverse events

IRB/EC Procedures
• Notify Investigator promptly of:
– Study-related decisions
– Reason for decisions
– Procedures for appeal of decisions

IRB/EC Required Records
• Relevant records maintained ≥ 3 yr after study
completion
• Records available for review by regulatory
authorities

IRB/EC What is Reviewed
• Investigator Brochure or Report of Prior Investigations
• Study protocol & amendments
• Investigator qualifications
• Informed consent documents, including subject
recruiting tools
• Other written information provided to subjects
• Subject compensation plans
• Adverse events
• Protocol deviations

IRB/EC When Reviews Occur
• Prior to study initiation at site
• At least yearly during study
• During study, as necessitated by:
– Changes in protocol, consent documents, etc.
– Changes in study investigator
– Reports of serious or unanticipated device-related adverse
events
• At study completion or termination

Investigator Roles &
Responsibilities
• Qualified to conduct study
• Have adequate resources to conduct study
• Provide medical care to study subjects
• Regular communication with IRB/EC reviewing study
• Compliance with study protocol
• Maintenance of investigational product accountability
• Compliance with study randomization & unmasking
procedures
• Provide informed consent to study subjects

Investigator Responsibilities
Appropriate Qualifications
• Training & experience demonstrated via:
– Medical license
– CV
– Specialized study training
– GCP training
• If study responsibilities delegated, need a list of qualified
persons to whom responsibilities are delegated

Adequate Resources
• Suitable staff & good methods for keeping them apprised
• Suitable facilities
• Appropriate patient population
– Access to disease or condition
– Volume of patients with disease or condition

Required Records & Reports
• Essential regulatory document file(s)
– Protocol & amendments
– Approved informed consent documents
– Product accountability documentation
– Investigator qualifications & agreements
– IRB correspondence
– Study delegation list
– Subject screening/enrollment logs
– Study monitoring reports
– Calibration/maintenance logs
– Memos to file

Sponsor
Roles & Responsibilities
• Study quality assurance
• Appropriately qualified medical personnel to advise on
study
• Utilization of qualified personnel in study design &
operations
• Study management, data handling & record keeping
• Investigator selection & training
• Definition/allocation of study responsibilities

Sponsor
• Facilitation of communications between Investigators
• Study compensation (investigators and/or subjects) &
financing
• Regulatory authority notification/submission
• Confirmation of IRB/EC review/approval
• Investigational product information
• Investigational product manufacturing, packaging,
labeling & coding
• Investigational product supply & handling28 March 2011 Department of Pharmaceutics 57

Sponsor
• Record access
• Ongoing safety evaluation & reporting
• Serious/unanticipated adverse event reporting
• Study monitoring
• Study noncompliance procedures
• Study termination or suspension notification
• Study reports

Sponsor
• Sponsor may transfer responsibilities to CRO
– Transfer must be documented in writing
– Sponsor still has ultimate responsibility for study quality and
data integrity

Study Protocol Components
• General administrative info
• Background
• Study purpose & objectives
• Study design
• Subject eligibility requirements
• How subjects will be treated
• How safety & efficacy will be assessed
• Sample size justification & statistical analysis methods

Study Protocol Components
• How data will be captured & maintained
• Monitoring procedures
• Proposed informed consent document

Informed Consent Document
Components
• Statement that study involves “research” & product
“experimental” (if applicable)
• Study purpose
• Number of expected study subjects to be enrolled
• Study treatment(s) & probability for random assignment
• Study exams & procedures for duration of trial
• Subject’s responsibilities
• Foreseeable risks to subject (embryo, fetus, nursing infant)

Components
• Expected benefits
• Alternatives procedures or therapies & associated
risk/benefit
• Compensation available in event of study-related injury
or sickness
• Anticipated payments to subject for study participation
• Anticipated expenses to subject for study participation
• Statement that participation is voluntary

Components
• Description of extent to which confidentiality can be
assured
• Commitment to keep subject apprised on new
information that may affect subject’s willingness to
participate in study
• Contact info for questions re: subject rights; trial-
related adverse events
• Circumstances under which subject’s participation
may be terminated

Investigator Brochure
What It Is
A compilation of clinical & non-clinical data on the
product that is relevant to the product’s study in
humans
Necessary for Investigator & IRB/EC review to
assess the risks/benefits associated with study

Investigator Brochure
Components
Product formulation summary
Introduction/background info regarding product &
investigational plan
• Investigational product physical, chemical &
pharmaceutical properties & formulation
• Non-clinical studies
• Human clinical studies
• Summary of data & guidance for Investigator

Good Clinical Practice
Reference Documents & Links
• ICH - E6: Guideline for Good Clinical Practice
• 21 CFR 50 - Informed Consent
• 21 CFR 56 - Institutional Review Board
• http://www.ich.org/cache/compo/276-254-1.html
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c

GLP – (Good Laboratory Practice)

What It Is GLP
• Describes good practices for non-clinical lab
studies that support research or marketing
approvals for FDA-regulated products

GLP General Requirements
• Appropriately qualified personnel
• Adequate resources
• Appropriate procedures for:
– Sanitation, health precautions, clothing
– Test protocol development, test methods
– Data analysis, report development
• Appropriately qualified study director
• Quality assurance function

GLP Facilities Requirements
• Suitable size, construction, segregation
– Animal care
– Animal supplies
– Test & control products maintained in a secure area
– Operating “suite”
– Specimen & data storage

GLP Equipment Requirements
• Appropriately designed
• Adequate thru-put capacity
• Appropriately located
• Routinely maintained & calibrated

GLP Standard Operating Procedures
• Animal room prep
• Animal care
• Receipt, ID, storage, handling, mixing & sampling of
test & control articles
• Test system observations
• Lab tests
• Handling of moribund or dead animals
• Necropsy or postmortem exams of animals

GLP Standard Operating Procedures
• Collection & ID of specimens
• Histopathology
• Data handling, storage & retrieval
• Equipment maintenance & calibration
• Transfer, proper placement & ID of animals

GLP Reagents & Solutions
• Adequate labeling
– Identity
– Concentration
– Storage requirements
– Expiration date

GLP Test & Control Articles
• Adequate characterization
• Proper receipt, storage, distribution
• When mixed with a carrier, adequate methods to
confirm
– Mixture uniformity
– Article concentration
– Article stability

GLP Study Implementation
• Written, approved protocol indicating test objectives
& methods
• Study conducted in accordance with protocol
• Study monitoring to confirm protocol compliance
• Appropriate labeling of specimens by test system,
study, nature & collection date
• Records of gross findings from postmortems
available to pathologist for specimen histopathology

GLP Study Implementation
• Standard data capture/recording requirements
– Legibility
– Permanence
– Accountability
– Changes

GLP Records & Reports
• Final report of results
• Study records & data methodically archived to
facilitate expedient retrieval
– Study documents
– Raw data
– Specimens
– Protocols
– QA inspections
– Personnel training & qualifications
– Calibration & maintenance records

GLP Records & Reports
• Records retention (shortest of):
– ≥ 2 yr after FDA marketing clearance
– ≥ 5 yr after data submitted to FDA in support of marketing
application
– ≥ 2 yr after Sponsor decision not to proceed with
marketing application
– Wet specimens hold as long as viable
• Records transferable with written FDA notification

GLP Facility Disqualification
• Grounds for disqualification:
– Failure to comply with regulations &
– Noncompliance adversely affects study validity &
– Previous regulatory actions have been unsuccessful in
modifying facility operations

GSP – (Good Storage Practice)

GSP – (Good Storage Practice)
1. Glossary
2. Personnel
3. Premises and facilities
4. Storage requirements
5. Returned goods
6. Dispatch and transport
7. Product recall

1. Glossary
a. Active pharmaceutical ingredient
b. Contamination
c. Cross-contamination
d. Excipient
e. Expiry date
f. Labelling

1. Glossary
g. Packaging material
h. Pharmaceutical product
i. Production
j. Retest date
k. Storage
l. Supplier

2. Personnel
• At each storage site (e.g. that of a manufacturer, distributor,
wholesaler, community or hospital pharmacy) there should
be an adequate number of qualified personnel to achieve
pharmaceutical quality assurance objectives.
• National regulations on qualifications should be followed.

2. Personnel
• All personnel should receive proper training in relation to
good storage practice, regulations, procedures and safety.
• All members of staff should be trained in, and observe high
levels of, personal hygiene and sanitation.
• Personnel employed in storage areas should wear suitable
protective or working garments appropriate for the activities
they perform

3. Premises and facilities
a. Storage areas
b. Storage conditions
c. Monitoring of storage conditions

4. Storage requirements
a. Documentation: written instructions and records
b. Labeling and containers
c. Receipt of incoming materials and pharmaceutical
products
d. Stock rotation and control

5. Returned goods
• Returned goods, including recalled goods, should be
handled in accordance with approved procedures and
records should be maintained.
• All returned goods should be placed in quarantine and
returned to saleable stock only after this has been
approved by a nominated, responsible person following a
satisfactory quality re-evaluation.
• Any stock reissued should be so identified and recorded in
stock records. Pharmaceuticals returned from patients to
the pharmacy should not be taken back as stock, but
should be destroyed.

6. Dispatch and transport
• Records for dispatch should be retained, stating at least:
— the date of dispatch;
— the customer’s name and address;
— the product description, e.g. name, dosage form and
strength (if appropriate), batch number and quantify;
— the transport and storage conditions.
• All records should be readily accessible and available on
request.

7. Product recall
• There should be a procedure to recall from the
market, promptly and effectively, pharmaceutical
products and materials known or suspected to be
defective.

GDP – (Good Distribution practice)

• GDP governs the proper distribution of medicinal
products for human use and regulates the
movement of products from the manufacturers’
premises (or other central point) to the end user (or
other intermediate point).

1. Principle
2. Personnel
3. Documentation
4. Premises and equipment
5. Deliveries to customers
6. Returns
7. Self inspection
8. Provision of information to Member States in relation
to wholesale activities

1. Principle
• Policy ensures that products released for distribution are of
the appropriate quality.
• In addition to this, the quality system should ensure that the
right products are delivered to the right addressee within a
satisfactory time period.
• A tracing system should enable any faulty product to be
found and there should be an effective recall procedure.

2. Personnel
• He should fulfil his responsibilities personally.
• Person should be appropriately qualified: although a degree
in Pharmacy is desirable, the qualification requirements
may be established by the Member State on whose territory
the wholesaler is located.

2. Personnel
• Key personnel involved in the warehousing of
medicinal products should have the appropriate
ability and experience to guarantee that the
products or materials are properly stored and
handled.
• Personnel should be trained in relation to the duties
assigned to them and the training sessions
recorded.

3. Documentation
• All documentation should be made available on
request of competent authorities
a. Orders
b. Procedures
c. Records

4. Premises and equipment
• Premises and equipment should be suitable and
adequate to ensure proper conservation and
distribution of medicinal products.
a. Receipt
b. Storage

• Deliveries should be made only to other authorised
wholesalers or to persons authorised to supply medicinal
products to the public in the Member State concerned.
• In case of emergency, wholesalers should be in a position
to supply immediately the medicinal products that they
regularly supply to the persons entitled to supply the
products to the public.

• Medicinal products should be transported in such a way
that :
a) Their identification is not lost;
b) They do not contaminate, and are not contaminated by,
other products or materials;
c) Adequate precautions are taken against spillage,
breakage or theft;
d) They are secure and not subjected to unacceptable
degrees of heat, cold, light, moisture or other adverse
influence, nor to attack by microorganisms or pests.

6. Returns
a. Returns of non-defective medicinal products
b. Emergency plan and recalls
c. Counterfeit medicinal products
d. Special provisions concerning products classified
as not for sale

7. Self inspection
• Self-inspections should be conducted 9and
recorded) in order to monitor the
implementation of and compliance with this
guideline.

8. Provision of information to Member
States in relation to wholesale activities
• Wholesalers wishing to distribute or distributing medicinal
products in Member State(s).
• Where appropriate, the competent authorities of this (these)
other Member State(s) will inform the wholesaler of any
public service obligation imposed on wholesalers operating
on their territory.

Guidance documents deal with GDP
• WHO Good Distribution Practice, Annex 5 to Technical Report
Series, No. 937, 2006
• Health Canada Guidelines for Temperature Control of Drug
Products during Storage and Transportation, 2005
• Irish Medicines Board Guide to Control and Monitoring of Storage
and Transportation Temperature Conditions for Medicinal Products
and Active Substances, 2006
• USP chapter <1079> Good Storage and Shipping Practice
• EU Guidelines on Good Distribution Practice of Medicinal Products
for Human Use (94/C 63/03)

GRP – (Good Review Practice)

• A good review practice (GRP) is a documented best
practice within CDER that discusses any aspect related to
the process, format, content, and/or management of a
product review.
• GRPs are developed over time as superior practices based
on CDER’s collective experience to provide consistency to
the overall review process of new products.
• GRPs are developed to improve the quality of reviews and
review management.

• GRPs improve efficiency, clarity, and transparency of the
review process and review management.
• GRPs are expected to be adopted by review staff as
standard processes through supervisor mentoring,
implementation teams, and formal training when necessary.
• Developing GRPs is an attempt to identify, collect,
enhance, implement, and adopt may of these best practices
as documented and standardized GRPs that can be shared
among all review division

− Quality — Consistent implementation of GRPs by review
staff will enhance the quality of reviews, the review process,
and the resultant regulatory action.
− Efficiency — GRPs will improve the efficiency of the review
process through standardization.
− Clarity — GRPs support clarity throughout the review
process, including critical review and decision activities that
must be completed before a regulatory decision is made.
GRPs Fundamental Values

GRPs Fundamental Values
− Transparency — Developing and documenting GRPs
ensures that our review processes are readily available in
one location via the Internet (through CDER’s Web site) to
sponsors and the public.
− Consistency — By offering a consistent approach and only
deviating from it when appropriate (after supervisory
concurrence), GRPs help reviewers achieve consistency
with their reviews and provide standard review processes
across divisions and offices.

cGxP

cGxP
• A "c" or "C" is sometimes added to the front of the acroynm.
• The preceding "c" stands for "current."
• For example, cGMP is an acronym for "current Good
Manufacturing Practices." cGMP is the most well known
example of a GxP.
• The term GxP is only used in a casual manner, to refer in a
general way to a collection of quality guidelines.

cGxP
• What does cGxP stand for?
• Current Good X Practice (FDA compliance; X can
mean: Manufacturing, Clinical, Laboratory, Storage,
Distribution, Review Pharmaceutical)

Thank you
Cell No: 00919742431000
E-mail: bknanjwade@yahoo.co.in

GxP and cGxP in Bio/Pharmaceutical Industry

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