GxP and cGxP in Bio/Pharmaceutical Industry

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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_at_yahoo.co.in
• Cell No 00919742431000

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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 Goodx (variable replaced with Manufacturing,
  Clinical,
• Laboratory, Storage, Distribution and
  Review) P Practice

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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.

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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
• Means21 Title 21CFR Code of Federal
  Regulations312.2 (312 part and 2 section)

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Lifecycle Requirements
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GxP

• GxP is a collective term for the Good Practice
  quality guidelines and regulations used in many
  fields, encompassing such internationally-recogniz
  ed 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.

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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.

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Core GXP Information
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Regional Harmonization Initiatives
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GxP
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List of GxPs in Pharmaceuticals

• GMP (Good manufacturing Practice)
• GCP (Good Clinical Practice)
• GLP (Good Laboratory Practice)
• GSP (Good Storage Practice)
• GDP (Good Distribution practice)
• GRP (Good Review Practice)

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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
• 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.

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Regulators
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GMP (Good Manufacturing Practice)
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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.

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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.

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GMP
QA
GMP
QC
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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!

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

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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

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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

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API Manufacturing Process
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Secondary Manufacturing Dosage Forms
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Secondary Manufacturing Process - Tablets
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Secondary Manufacturing Process Sterile
parenteral for injection
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Packaging
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Packaging
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Packaging
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Biotechnology Manufacturing Process
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Ten 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
• Design ,develop and demonstrate job competence
• Protect against contamination
• Control components and product related processes
  
• Conduct planned and periodic audits

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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

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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 reputation

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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)

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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

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GCP (Good Clinical Practice)
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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

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GCP Participating Parties

• IRB/Ethics Committee
• Investigators
• Sponsor
• Regulatory Authorities

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GCP Key Documents

• Investigator Brochure
• Study Protocol
• Informed Consent Document

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GCP Principles

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

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GCP Principles

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

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GCP Principles

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

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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

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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

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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)

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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

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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

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IRB/EC Procedures

• Notify Investigator promptly of
• Study-related decisions
• Reason for decisions
• Procedures for appeal of decisions

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IRB/EC Required Records

• Relevant records maintained 3 yr after study
  completion
• Records available for review by regulatory
  authorities

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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

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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

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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

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Investigator ResponsibilitiesAppropriate
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

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Investigator ResponsibilitiesAdequate 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

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Investigator ResponsibilitiesRequired 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

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SponsorRoles 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

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SponsorRoles Responsibilities

• 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 handling

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SponsorRoles Responsibilities

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

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SponsorRoles Responsibilities

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

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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

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Study Protocol Components

• How data will be captured maintained
• Monitoring procedures
• Proposed informed consent document

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Informed Consent DocumentComponents

• 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
• Subjects responsibilities
• Foreseeable risks to subject (embryo, fetus,
  nursing infant)

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Informed Consent DocumentComponents

• 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

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Informed Consent DocumentComponents

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

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Investigator BrochureWhat It Is

• A compilation of clinical non-clinical data on
  the product that is relevant to the products
  study in humans
• Necessary for Investigator IRB/EC review to
  assess the risks/benefits associated with study

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Investigator BrochureComponents

• 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

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Good Clinical PracticeReference 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/
  cfcfr/cfrsearch.cfm

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GLP (Good Laboratory Practice)
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What It Is GLP

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

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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

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GLP Facilities Requirements

• Suitable size, construction, segregation
• Animal care
• Animal supplies
• Test control products maintained in a secure
  area
• Operating suite
• Specimen data storage

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GLP Equipment Requirements

• Appropriately designed
• Adequate thru-put capacity
• Appropriately located
• Routinely maintained calibrated

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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

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GLP Standard Operating Procedures

• Collection ID of specimens
• Histopathology
• Data handling, storage retrieval
• Equipment maintenance calibration
• Transfer, proper placement ID of animals

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GLP Reagents Solutions

• Adequate labeling
• Identity
• Concentration
• Storage requirements
• Expiration date

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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

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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

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GLP Study Implementation

• Standard data capture/recording requirements
• Legibility
• Permanence
• Accountability
• Changes

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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

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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

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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

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GSP (Good Storage Practice)
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GSP (Good Storage Practice)

• Glossary
• Personnel
• Premises and facilities
• Storage requirements
• Returned goods
• Dispatch and transport
• Product recall

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1. Glossary

• Active pharmaceutical ingredient
• Contamination
• Cross-contamination
• Excipient
• Expiry date
• Labelling

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1. Glossary

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

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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.

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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

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3. Premises and facilities

• Storage areas
• Storage conditions
• Monitoring of storage conditions

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4. Storage requirements

• Documentation written instructions and records
• Labeling and containers
• Receipt of incoming materials and pharmaceutical
  products
• Stock rotation and control

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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.

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6. Dispatch and transport

• Records for dispatch should be retained, stating
  at least
• the date of dispatch
• the customers 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.

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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.

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GDP (Good Distribution practice)
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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).

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GDP (Good Distribution practice)

• Principle
• Personnel
• Documentation
• Premises and equipment
• Deliveries to customers
• Returns
• Self inspection
• Provision of information to Member States in
  relation to wholesale activities

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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.

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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.

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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.

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3. Documentation

• All documentation should be made available on
  request of competent authorities
• Orders
• Procedures
• Records

100
4. Premises and equipment

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

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5. Deliveries to customers

• 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.

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5. Deliveries to customers

• 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.

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6. Returns

• Returns of non-defective medicinal products
• Emergency plan and recalls
• Counterfeit medicinal products
• Special provisions concerning products classified
  as not for sale

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7. Self inspection

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

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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.

106
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 lt1079gt Good Storage and Shipping
  Practice
• EU Guidelines on Good Distribution Practice of
  Medicinal Products for Human Use (94/C 63/03)

107
GRP (Good Review Practice)
108
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 CDERs 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.

109
GRP (Good Review Practice)

• 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

110
GRPs Fundamental Values

• - 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.

111
GRPs Fundamental Values

• - Transparency Developing and documenting GRPs
  ensures that our review processes are readily
  available in one location via the Internet
  (through CDERs 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.

112
cGxP
113
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.

114
cGxP

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

115
Thank you
Cell No 00919742431000 E-mail
bknanjwade_at_yahoo.co.in