CGMP Requirements for Investigational Products

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1 PREP #6 CGMP Requirements for Investigational Products Ji-Eun Kim, RPh, PhD Research Pharmacist Regulatory Affairs Office of Research Compliance December 6,

2 CME Disclosure Statement Northwell Health adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by Northwell Health for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Peter Berger, MD and Tina Chuck, MPH have nothing to disclose. Ji-Eun Kim has nothing to disclose. 2

3 Objectives Describe current regulatory requirements to ensure quality and safety of investigational products used in clinical research 3

4 Outline Case Studies Exercises Regulations Options Encapsulation Repackaging Sterile Product New Product Development 4

5 CASE STUDY #1 Encapsulating commercial products 5

6 Discussion Where can your research team purchase a blinded product and placebo? 6

7 Definitions Drug A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body. Drug Product Drug product means a finished dosage form, e.g., tablet, capsule, solution, etc., that generally contains an active drug ingredient. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. FDA Glossary; 21 CFR

8 Federal Regulations 21 CFR 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 21 CFR 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 21 CFR 600 BIOLOGICAL PRODUCTS: GENERAL CFR: Code of Federal Regulations 8

9 What is Current Good Manufacturing Practice Purpose (CGMP)? Minimum requirements for methods, facilities and control for processing, manufacturing and packaging of a drug product. Intended to prevent manufacturing defects, failures of performance/efficacy, contamination, mix-ups, deviations. 9

10 What is CGMP? Elements Organization and Personnel Buildings and Facilities Equipment Control of Components and Drug Product Containers and Closures Production and Process Controls Packaging and Labeling Control Holding and Distribution Laboratory Controls Records and Reports Returned and Salvaged Drug Products 21 CFR 211 CGMP for Finished Pharmaceuticals 10

11 New York State Rules Any drug, device or cosmetic shall be deemed to be adulterated and/or misbranded if: It is not manufactured in accordance with the good manufacturing practices specified in Parts 210 and 211 of Title 21, Code of Federal Regulations,. At any time it fails to meet standards for purity, potency, labeling, safety and effectiveness established under the Federal Food, Drug and Cosmetic Act, as amended. NYS Rules of the Board of Regents, Part

12 EXERCISE #1 How about investigational drugs? TRUE or FALSE FDA Guidance 12

13 True or False? #1 The FDA, recognizing the differences between the manufacture of investigational products and commercial products, believes that it is not necessary that investigational products be made in conformance with current good manufacturing practice (CGMP). 13

14 True or False? #2 Investigational products, unlike products approved for marketing, have not been subject to the FDA s CGMP inspectional activities. 14

15 FDA Guidance #1: The FDA, while recognizing the differences between the manufacture of investigational products and commercial products, believes that it is nonetheless vital that investigational products be made in conformance with current good manufacturing practice (CGMP). #2: Investigational products, like products approved for marketing, have always been subject to the FDA s CGMP inspectional activities. FDA Guidance: Preparation of Investigational New Drug Products 15

16 EXERCISE #2 How about the GCP standards? FILL IN THE BLANKS E6 Good Clinical Practices (GCP) 16

17 Fill in the Blanks # Investigational products should be manufactured, handled and stored in accordance with applicable (a). 17

18 Fill in the Blanks # Manufacturing, Packaging, Labeling and Coding Investigational product(s) (b) should ensure that the investigational product(s) (including active comparator(s) and (c), if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable (d) and is coded and labeled in a manner that protects the blinding, if applicable. In addition, the labeling should comply with applicable regulatory requirement(s). 18

19 E6 Good Clinical Practices (GCP) # Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol. #2 Manufacturing, Packaging, Labeling and Coding Investigational product(s) The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP and is coded and labeled in a manner that protects the blinding, if applicable. In addition, the labeling should comply with applicable regulatory requirement(s). 19

20 How does CGMP affect your research? If an external sponsor provides investigational drug(s) (ID) If the PI is the sponsor-investigator or the PI procures the ID The sponsor usually ensures the production of ID under CGMP standards in protocol, Investigator s Brochure & other documents. If not, request the sponsor to provide product quality assurance. The PI assumes sponsor s responsibilities. The PI must ensure CGMP compliance or quality and safety of the ID. 20

21 CASE STUDY #1 Cont d Encapsulating commercial products 21

22 Compounding What is compounding? In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. 22

23 Compounding Why do some patients need compounded drugs? Sometimes, the health needs of a patient cannot be met by an FDA-approved medication. For example: - Patient allergies to excipients in commercial products - Dose adjustments - Special formulations (e.g., alternative dosage forms, flavors) - Drug shortage 23

24 EXERCISE #3 Compounding Pharmacy? TRUE or FALSE Federal Law 24

25 True or False? #1 A blinded drug and placebo product purchased in bulk from a compounding pharmacy are manufactured in compliance with CGMP requirements. 25

26 True or False? #2 You cannot purchase modified or compounded drugs from a compounding pharmacy without prescriptions. 26

27 Federal Law To be exempt from CGMP, labeling of drugs & *NDAs/*ANDAs requirements Prescription for identified individuals By a licensed pharmacist in a state licensed pharmacy or a Federal facility, or by a licensed physician Applicable *USP/NF Drug Quality and Security Act (DQSA) Title I: Compounding Quality Act (CQA) Section 503A 27

28 Discussion Can a research team purchase a blinded commercial product and placebo from a compounding pharmacy? 28

29 Options Encapsulating commercial products CGMP If you decide to stock blinded products, You must purchase blinded investigational products including placebo from a CGMP-compliant manufacturer. 503A The PI can issue a prescription for a specific subject at each dispensation. Pharmacist prepares encapsulated products only after receiving a prescription. Comply with records, labeling, expiration date and other applicable requirements. *See the definition in the handout. 29

30 30

31 CASE STUDY #2 Repackaging commercial products 31

32 Repackaging What is repackaging? The act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug. Repackaging also includes the act of placing the contents of multiple containers (e.g., vials) of the same finished drug product into one container, as long as the container does not include other ingredients. FDA Guidance Draft: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities 32

33 Repackaging Why do some patients need repackaged drugs? To meet the needs of specific groups of patients To reduce medication errors To reduce the availability of drug products of abuse To provide a particular sized container to fit into a particular device to administer the drug For convenience for the practitioner administering an injection to a patient To reduce cost Some repackagers repackage both sterile and non-sterile drug products. FDA Guidance Draft: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities 33

34 EXERCISE #4 Repackaging? TRUE or FALSE FDA Guidance 34

35 Question: Repackaging? #1 A nurse draws up a syringe to administer directly to the patient after receipt of a patient-specific prescription or order for that patient. 35

36 Question: Repackaging? #2 Upon receipt of an individual patient-specific prescription, a licensed pharmacist removes oral tablets from one container and places them into a smaller container to dispense directly to the patient. 36

37 Question: Repackaging? #3 Drug tablets are packaged from large containers into smaller containers or blister packs in anticipation for dispensations. 37

38 Question: Repackaging? #4 Creams and lotions are purchased in bulk and packaged into smaller tubes or containers for office use. 38

39 Repackaging Who can repackage a drug product? Repackaged drug products are generally NOT exempt from any of the provisions of the FD&C Act (CGMP, labeling of drugs & NDAs/ANDAs) related to the production of drugs. Therefore, drug products that do not meet the conditions, including drug products repackaged by entities that are NOT state-licensed pharmacies, Federal facilities, or outsourcing facilities, generally must comply with requirements in the FD&C Act and FDA regulations. FDA Guidance Draft: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities 39

40 Discussion Can your research team repackage a product and placebo at your site? 40

41 Options Repackaging commercial products CGMP If you decide to stock repackaged products, You must purchase blinded investigational products including placebo from a CGMP-compliant manufacturer. FDA Guidance The PI can issue a prescription for a specific subject at each dispensation. Pharmacist prepares repackaged products only after receiving a prescription. Comply with records, labeling, expiration date and other applicable requirements. 41

42 Outcome of CGMP Non-compliance Month Day, Year 42

43 FDA Warning Letter An individual or firm compounds a drug product that does not meet the conditions of section 503A. Producing Adulterated Drugs CGMP requirements Producing Unapproved New Drugs Approved NDA or ANDA Misbranded Drugs Labeled with adequate directions for use 43

44 44

45 CASE STUDY #3 Blinding commercial sterile products 45

46 Discussion Any issues with this plan? 46

47 CASE STUDY #3 Cont d Blinding commercial sterile products 47

48 Regulatory Background Aseptic Manipulations United States Pharmacopeia (USP) Chapter 797 Pharmaceutical Compounding Sterile Preparations NYS Rules for Compounded Sterile Preparations Northwell policy INF.1158 Medication Vial, Infusion and Safe Injection Practice Guidelines Beyond-Use Date FDA Guidance Draft Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Stability Sterility Facility policy Time frames

49 EXERCISE #5 Select applicable considerations for repackaging a commercially available sterile product. a. Product degradation b. Microbial contamination c. Impurities d. Beyond-use-date assignment 49

50 Discussion Can the delegated unblinded pharmacist prepare and stock blinded syringes to expedite immediate dispensation upon receiving a drug order? 50

51 Options Blinding commercial sterile products CGMP/503B If you decide to stock the products, You must purchase blinded investigational products including placebo from a CGMP-compliant manufacturer/outsourcing facility*. 503A/USP797 The PI can issue a prescription or drug order for a specific subject at each dispensation. Pharmacist prepares the product only after receiving a prescription or drug order. Comply with records, labeling, expiration date and other applicable requirements. 51

52 Outcome of Non-compliance 52

53 Outcome of Non-compliance 53

54 54

55 CASE STUDY #4 Developing new investigational products 55

56 EXERCISE #6 New APIs* in development? TRUE or FALSE ICH GMP Guide Q7 * APIs: Active Pharmaceutical Ingredients 56

57 True or False? #1 Appropriate GMP concepts should be applied in the production of APIs. 57

58 True or False? #2 Process and test procedures should be flexible to provide changes. 58

59 True or False? #3 APIs are manufactured in suitable facilities using appropriate production and control procedures. 59

60 ICH GMP Guide Q7 Active Pharmaceutical Ingredients (APIs) for use in clinical trials Appropriate GMP concepts should be applied in the production of APIs with a suitable mechanism of approval of each batch. Process and test procedures should be flexible to provide for changes as knowledge of the process increases and clinical testing of a drug product progresses. APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API. 60

61 Discussion What types of information does the PI need to submit to the FDA regarding the product quality and safety assurance? 61

62 FDA Guidance IND Contents Chemistry, manufacturing and control information (CMC) Sufficient information to assure the proper identification, quality, purity and strength Stability data FDA Guidance: IND prepared and submitted by sponsor-investigators (Draft) Content and format of INDs for phase 1 studies 62

63 FDA Guidance Manufacturing of investigational drugs Well-defined, written procedures Adequately controlled equipment and manufacturing environment Accurately and consistently recorded data from manufacturing and testing FDA Guidance: Guideline on the preparation of IND products CGMP for phase 1 investigational drugs 63

64 FDA Guidance Botanical drug development Botanical raw material control Quality control by chemical test Biological assay FDA Guidance: Botanical drug development (Draft) 64

65 Option Developing new investigational products CMC information Physical, chemical and biological characteristics Manufacturers Source and method of preparation Quality controls (identity, assay, purity, impurities profile) Formulation Sterility Stability data Current Good Laboratory Practices (CGLP) compliant data FDA pre-ind consultation program 65

66 Outcome of Non-compliance An IND submission that lacks the proper CMC information could be placed on clinical hold. FDA may also terminate an IND if it lacks the requisite CMC information. Generally, however, FDA will not terminate an IND until after first attempting to resolve the issues. 66

67 Other Cases Online Pharmacy Dietary Supplements Packaging Labeling 67

68 Questions?

69 CONTACT INFORMATION Office of Research Compliance TEL: Ji-Eun Kim, RPh, PhD Research Pharmacist Regulatory Affairs Office of Research Compliance TEL:

70 Thank You 70

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