Quality Program: Supplies and Reagents

Transcription

1 Quality Program: Supplies and Reagents J. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ) Supervisor, Quality Assurance and Regulatory Affairs Department of Transfusion Medicine, Clinical Center, NIH

2 Disclosures: I have no financial conflicts of interest. The presentation and comments today are my own and not necessarily those of the Department of Health and Human Services, NIH, the Clinical Center or DTM. They do reflect the current, approved policies and practices of the DTM, CC, NIH.

3 Why Do We need to have a Systematic Approach for managing supplies and reagents? All materials used to manufacture and HCTP product, including the cells themselves must be selected to meet the intended use They must come from a qualified source They must be validated or verified to perform as expected They must be used in a controlled manner Within expiry dating Performing as expected at the time of use (within quality control range) Assessed for acceptability (visual inspection for appearance, color, etc ) Last, but not least; It is a regulated requirement

4 Regulations: Sec Supplies and reagents. (a) Verification. You must not use supplies and reagents until they have been verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases. Verification may be accomplished by the establishment that uses the supply or reagent, or by the vendor of the supply or reagent. (b) Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate. (c) In-house reagents. You must validate and/or verify the processes used for production of in-house reagents. (d) Records. You must maintain the following records pertaining to supplies and reagents: (1) Records of the receipt of each supply or reagent, including the type, quantity, manufacturer, lot number, date of receipt, and expiration date; (2) Records of the verification of each supply or reagent, including test results or, in the case of vendor verification, a certificate of analysis from the vendor; and (3) Records of the lot of supply or reagent used in the manufacture of each HCT/P.

5 More regulations: Sec What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? a) Accompanying records. Once a donor-eligibility determination has been made, the following must accompany the HCT/P at all times: (1) A distinct identification code affixed to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to the donor and to all records pertaining to the HCT/P and, except in the case of autologous donations, directed reproductive donations, or donations made by first-degree or second-degree blood relatives, does not include an individual's name, social security number, or medical record number;

6 More regulation: Sec Receipt, predistribution shipment, and distribution of an HCT/P. c) Availability for distribution. (1) Before making an HCT/P available for distribution, you must review manufacturing and tracking records pertaining to the HCT/P, and, on the basis of that record review, you must verify and document that the release criteria have been met. A responsible person must document and date the determination that an HCT/P is available for distribution. e) Procedures. You must establish and maintain procedures, including release criteria, for the activities in paragraphs (a) through (d) of this section. You must document these activities. Documentation must include: (1) Identification of the HCT/P and the establishment that supplied the HCT/P;

7 Guidance: Guidance for Industry Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research December 2011

8 Guidance: Under (a), you must control your storage areas and stock rooms to prevent the following: mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents; and an HCT/P being improperly made available for distribution. Each storage area should have signs indicating the types of supplies, reagents, and HCT/Ps contained in that area, and should be organized to prevent mix-ups, crosscontamination, and improper release of HCT/Ps.

9 continued: A. What Are Supplies and Reagents? Supplies and reagents include all materials that are used during manufacture, not just those coming into direct contact with HCT/Ps. Examples of supplies include sterile drapes, gauze, cleaning swabs, alcohol pads, and instruments (equipment) that are cleaned and sterilized under contract, agreement or other arrangement for you. Examples of reagents include cleaning agents, saline, dimethyl sulfoxide, anticoagulants, and chemical and antibiotic solutions used in processing.

10 continued: B. What Verification is Required for Supplies and Reagents? Under (a), you must not use supplies and reagents until they have been verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases. Verification may be accomplished by the establishment that uses the supply or reagent, or by the vendor of the supply or reagent ( (a)). You or a vendor must verify that those supplies and reagents used in all steps of the manufacture of HCT/Ps (not only those that come in contact with an HCT/P), including recovery, meet specifications designed to prevent circumstances that increase the risk of introduction, transmission, or spread of communicable diseases (see (a)

11 continued: We recommend that you keep product information data sheets for all supplies and reagents used, update these sheets as products change, and keep an archive of previously used products. Verification that reagents meet specifications may be accomplished either by reviewing the Certificate of Analysis (COA) or by performing relevant testing. For supplies such as sterile drapes or gloves that are not expected to have a COA, we recommend that you obtain information from the vendor on the relevant specifications and the manufacturing of the supply. If you receive supplies and/or reagents from a vendor or another establishment, you should verify that the vendor or other establishment has a system in place to certify that the supplies and/or reagents meet established specifications. You could reference specification sheets, COAs, and manufacturer s package inserts describing the reagent and/or supply to verify suitability.

12 Continued : You must validate and/or verify the processes used for production of in-house reagents ( (c)). For example, in the case of reagents produced for disinfecting recovery processes, the recovery establishment must verify that these reagents meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission or spread of communicable diseases (e.g., solutions are sterile, where appropriate, have the proper concentrations, and fall within a specific ph range). (See (a) through (c)). Under (d), you must maintain the following records pertaining to supplies and reagents: records of the receipt of each supply or reagent, including the type, quantity, manufacturer, lot number, date of receipt, and expiration date; records of the verification of each supply or reagent, including test results or, in the case of vendor verification, a COA from the vendor; and records of the lot of supply or reagent used in the manufacture of each HCT

13 Critical Task: Vendor/Supplier Qualification Human Cells and Tissues, critical services, equipment, software, supplies, ancillary materials, test kits and reagents obtained from outside sources should be reviewed to assure they meet your pre-defined requirements for safety, quality and fitness for use. This may be referred to as Vendor Supplier Qualification. The goal of supplier qualification is to provide assurance that materials and services from external sources meet your needs with no or minimal re-work to make it suitable for your use.

14 A risk based, tiered approach to qualifying vendors suppliers Hardware, reagents and supplies pose less risk for harm than software or final, finished products for transfusion or infusions. Licensed products, software, hardware, reagents and supplies pose less risk than nonlicensed, reviewed ones. Tiers of qualification and documentation can be assigned based on level of risk of harm. Higher risk supplies, reagents or products need more pre-qualification work.

15 Tier 1: Low risk Vendors or suppliers that are FDA licensed manufacturers may be considered qualified if the vendor can provide documentation of licensure. Keep the records provided by the vendor on file as reference of their claim

16 Tier 2: Moderate Risk Vendors or suppliers that are not FDA licensed manufacturers may be considered qualified if they have a quality management system in place that would allow them to be licensed by the FDA or accredited by a third party reviewer such as ISO, AABB, or FACT. At minimum the Quality Plan Outline or Table of Contents should be reviewed to assure the quality system covers are critical systems needed to assure the consistent production or supplies or reagents that meet all quality requirements. Many vendors have this packet prepared in advance and is made available through their QA department. Keep the records provided by the vendor on file as reference of their claim

17 Tier 3: Highest Risk This is Tier is reserved for products or materials that will be directly infused or implanted into a recipient, but are not FDA licensed products or products developed under an FDA approved IND/IDE. Suppliers of HCT/Ps or other biological materials used to manufacture HCT/Ps that are not FDA licensed nor under an FDA approved IND, may be considered qualified if a trained quality associate, skilled in review of quality systems conducts an on site inspection of the quality system and manufacturing system or the vendor supplier produces documentation sufficient to make a valid determination in a desk audit. This is usually conducted via an extended telephone interview with several members of the vendor/supplier s management team.