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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.

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Presentation on theme: "GxP and cGxP in Bio/Pharmaceutical Industry Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy."— Presentation transcript:

1 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: Cell No: 00919742431000 28 March 20111Department of Pharmaceutics

2 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

3 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. 3Department of Pharmaceutics28 March 2011

4 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) 4Department of Pharmaceutics28 March 2011

5 Lifecycle Requirements 5Department of Pharmaceutics28 March 2011

6 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. 6Department of Pharmaceutics28 March 2011

7 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.qualitypharmaceutical The titles of these good practice guidelines usually begin with " G ood" and end in " P ractice", 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. 7Department of Pharmaceutics28 March 2011

8 Core GXP Information 8Department of Pharmaceutics28 March 2011

9 Regional Harmonization Initiatives 9Department of Pharmaceutics28 March 2011

10 GxP 10Department of Pharmaceutics28 March 2011

11 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) 11Department of Pharmaceutics28 March 2011

12 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

13 Regulators 13Department of Pharmaceutics28 March 2011

14 GMP – (Good Manufacturing Practice) 28 March 2011Department of Pharmaceutics14

15 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. 28 March 2011Department of Pharmaceutics15

16 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. 28 March 2011Department of Pharmaceutics16

17 GMP 28 March 2011Department of Pharmaceutics17 QC GMP QA

18 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! 28 March 2011Department of Pharmaceutics18

19 GMP 28 March 2011Department of Pharmaceutics19 GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use

20 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 28 March 2011Department of Pharmaceutics20

21 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 21Department of Pharmaceutics28 March 2011

22 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 28 March 2011Department of Pharmaceutics22

23 API Manufacturing Process 23Department of Pharmaceutics28 March 2011

24 Secondary Manufacturing Dosage Forms 24Department of Pharmaceutics28 March 2011

25 Secondary Manufacturing Process - Tablets 25Department of Pharmaceutics28 March 2011

26 Secondary Manufacturing Process – Sterile parenteral for injection 26Department of Pharmaceutics28 March 2011

27 Packaging 27Department of Pharmaceutics28 March 2011

28 Packaging 28Department of Pharmaceutics28 March 2011

29 Packaging 29Department of Pharmaceutics28 March 2011

30 Biotechnology Manufacturing Process 30Department of Pharmaceutics28 March 2011

31 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 28 March 2011Department of Pharmaceutics31

32 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 28 March 2011Department of Pharmaceutics32

33 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 28 March 2011Department of Pharmaceutics33

34 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) 28 March 2011Department of Pharmaceutics34

35 Cost / benefit analysis 28 March 2011Department of Pharmaceutics35 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

36 GCP – (Good Clinical Practice) 28 March 2011Department of Pharmaceutics36

37 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 28 March 2011Department of Pharmaceutics37

38 GCP Participating Parties IRB/Ethics Committee Investigators Sponsor Regulatory Authorities 28 March 2011Department of Pharmaceutics38

39 GCP Key Documents Investigator Brochure Study Protocol Informed Consent Document 28 March 2011Department of Pharmaceutics39

40 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 28 March 2011Department of Pharmaceutics40

41 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 28 March 2011Department of Pharmaceutics41

42 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 28 March 2011Department of Pharmaceutics42

43 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 28 March 2011Department of Pharmaceutics43

44 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 28 March 2011Department of Pharmaceutics44

45 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) 28 March 2011Department of Pharmaceutics45

46 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 28 March 2011Department of Pharmaceutics46

47 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 28 March 2011Department of Pharmaceutics47

48 IRB/EC Procedures Notify Investigator promptly of: – Study-related decisions – Reason for decisions – Procedures for appeal of decisions 28 March 2011Department of Pharmaceutics48

49 IRB/EC Required Records Relevant records maintained ≥ 3 yr after study completion Records available for review by regulatory authorities 28 March 2011Department of Pharmaceutics49

50 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 28 March 2011Department of Pharmaceutics50

51 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 28 March 2011Department of Pharmaceutics51

52 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 28 March 2011Department of Pharmaceutics52

53 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 28 March 2011Department of Pharmaceutics53

54 Investigator Responsibilities 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 28 March 2011Department of Pharmaceutics54

55 Investigator Responsibilities 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 28 March 2011Department of Pharmaceutics55

56 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 28 March 2011Department of Pharmaceutics56

57 Sponsor Roles & 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 28 March 2011Department of Pharmaceutics57

58 Sponsor Roles & Responsibilities Record access Ongoing safety evaluation & reporting Serious/unanticipated adverse event reporting Study monitoring Study noncompliance procedures Study termination or suspension notification Study reports 28 March 2011Department of Pharmaceutics58

59 Sponsor Roles & Responsibilities Sponsor may transfer responsibilities to CRO – Transfer must be documented in writing – Sponsor still has ultimate responsibility for study quality and data integrity 28 March 2011Department of Pharmaceutics59

60 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 28 March 2011Department of Pharmaceutics60

61 Study Protocol Components How data will be captured & maintained Monitoring procedures Proposed informed consent document 28 March 2011Department of Pharmaceutics61

62 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) 28 March 2011Department of Pharmaceutics62

63 Informed Consent Document 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 28 March 2011Department of Pharmaceutics63

64 Informed Consent Document 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 28 March 2011Department of Pharmaceutics64

65 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 28 March 2011Department of Pharmaceutics65

66 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 28 March 2011Department of Pharmaceutics66

67 Good Clinical Practice Reference Documents & Links ICH - E6: Guideline for Good Clinical Practice 21 CFR 50 - Informed Consent 21 CFR 56 - Institutional Review Board cs/cfcfr/cfrsearch.cfm cs/cfcfr/cfrsearch.cfm 28 March 2011Department of Pharmaceutics67

68 GLP – (Good Laboratory Practice) 28 March 2011Department of Pharmaceutics68

69 What It Is GLP Describes good practices for non-clinical lab studies that support research or marketing approvals for FDA-regulated products 28 March 2011Department of Pharmaceutics69

70 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 28 March 2011Department of Pharmaceutics70

71 GLP Facilities Requirements Suitable size, construction, segregation – Animal care – Animal supplies – Test & control products maintained in a secure area – Operating “suite” – Specimen & data storage 28 March 2011Department of Pharmaceutics71

72 GLP Equipment Requirements Appropriately designed Adequate thru-put capacity Appropriately located Routinely maintained & calibrated 28 March 2011Department of Pharmaceutics72

73 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 28 March 2011Department of Pharmaceutics73

74 GLP Standard Operating Procedures Collection & ID of specimens Histopathology Data handling, storage & retrieval Equipment maintenance & calibration Transfer, proper placement & ID of animals 28 March 2011Department of Pharmaceutics74

75 GLP Reagents & Solutions Adequate labeling – Identity – Concentration – Storage requirements – Expiration date 28 March 2011Department of Pharmaceutics75

76 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 28 March 2011Department of Pharmaceutics76

77 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 28 March 2011Department of Pharmaceutics77

78 GLP Study Implementation Standard data capture/recording requirements – Legibility – Permanence – Accountability – Changes 28 March 2011Department of Pharmaceutics78

79 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 28 March 2011Department of Pharmaceutics79

80 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 28 March 2011Department of Pharmaceutics80

81 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 28 March 2011Department of Pharmaceutics81

82 GSP – (Good Storage Practice) 28 March 2011Department of Pharmaceutics82

83 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 83Department of Pharmaceutics28 March 2011

84 1. Glossary a.Active pharmaceutical ingredient b.Contamination c.Cross-contamination d.Excipient e.Expiry date f.Labelling 28 March 2011Department of Pharmaceutics84

85 1. Glossary g. Packaging material h. Pharmaceutical product i. Production j. Retest date k. Storage l. Supplier 28 March 2011Department of Pharmaceutics85

86 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. 28 March 2011Department of Pharmaceutics86

87 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 28 March 2011Department of Pharmaceutics87

88 3. Premises and facilities a.Storage areas b.Storage conditions c.Monitoring of storage conditions 28 March 2011Department of Pharmaceutics88

89 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 28 March 2011Department of Pharmaceutics89

90 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. 28 March 2011Department of Pharmaceutics90

91 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. 28 March 2011Department of Pharmaceutics91

92 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. 28 March 2011Department of Pharmaceutics92

93 GDP – (Good Distribution practice) 28 March 2011Department of Pharmaceutics93

94 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). 94Department of Pharmaceutics28 March 2011

95 GDP – (Good Distribution practice) 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 28 March 2011Department of Pharmaceutics95

96 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. 28 March 2011Department of Pharmaceutics96

97 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. 28 March 2011Department of Pharmaceutics97

98 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. 28 March 2011Department of Pharmaceutics98

99 3. Documentation All documentation should be made available on request of competent authorities a.Orders b.Procedures c.Records 28 March 2011Department of Pharmaceutics99

100 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 28 March 2011Department of Pharmaceutics100

101 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. 28 March 2011Department of Pharmaceutics101

102 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. 28 March 2011Department of Pharmaceutics102

103 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 28 March 2011Department of Pharmaceutics103

104 7. Self inspection Self-inspections should be conducted 9and recorded) in order to monitor the implementation of and compliance with this guideline. 28 March 2011Department of Pharmaceutics104

105 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. 28 March 2011Department of Pharmaceutics105

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 Good Storage and Shipping Practice EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) 106Department of Pharmaceutics28 March 2011

107 GRP – (Good Review Practice) 28 March 2011Department of Pharmaceutics107

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 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. 28 March 2011Department of Pharmaceutics108

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 28 March 2011Department of Pharmaceutics109

110 − 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. 28 March 2011Department of Pharmaceutics110 GRPs Fundamental Values

111 − 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. 28 March 2011Department of Pharmaceutics111

112 cGxP 28 March 2011Department of Pharmaceutics112

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. 113Department of Pharmaceutics28 March 2011

114 cGxP What does cGxP stand for? Current Good X Practice (FDA compliance; X can mean: Manufacturing, Clinical, Laboratory, Storage, Distribution, Review Pharmaceutical) 114Department of Pharmaceutics28 March 2011

115 Department of Pharmaceutics115 Thank you Cell No: 00919742431000 E-mail:

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