Standards for Laboratory Facilities

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1 Standards for Laboratory Facilities Version 2.1 APPROVED 24 FEBRUARY 2014

2 Article I. General Provisions Section 1.01 The facility shall be of suitable size and construction to facilitate the proper conduct of prescribed laboratory activities. Section 1.02 There shall be a separate and unique laboratory space provided. Section 1.03 The facility shall provide a written procedure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. Section 1.04 The facility shall maintain a quality assurance unit. Section 1.05 The process used to process the tissue into a cellular application shall be approved by an Institutional Review Board. Section 1.06 If the facility maintains a clean room, it shall provide proof of class. Section 1.07 If the facility is cgmp it shall provide proof of approved status. Section 1.08 If the facility is licensed by any local, national and/or federal agency, then it shall provide evidence of inspection and approval. Section 1.09 If the facility accredited now, or previously, by any governmental or nongovernmental agency, it shall provide evidence of accreditation. Article II. Physical Plant and Facilities Section 2.01 The laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Section 2.02 To prevent contamination or mix-ups, the facility shall provide separate areas for receipt and storage of the samples.

3 Section 2.03 The laboratory ceiling surface or drop-in tiles shall be smooth, washable and free of particulate matters Section 2.04 The laboratory work surfaces shall be covered with smooth and easy to clean material that is free from tears, breaks or cracks. Section 2.05 The laboratory floors shall be sealed and covered with an appropriate material which is smooth and free from breaks or cracks. Section 2.06 The facility shall maintain back-up power or a generator in the case of loss of power.

4 Article III. Standard Operating Procedures Section 3.01 An historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions shall be maintained. Section 3.02 As needed and determined by the processing protocol, the facility shall maintain a written, standard operating procedure (SOP): (a) That written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations. (b) For the receipt, identification, storage, handling, mixing, and method of sampling of the samples. (c) For test system observations. (d) For laboratory tests. (e) For the collection and identification of samples. (f) For histopathology. (g) For data handling, storage, and retrieval. (h) For the maintenance and calibration of equipment. (i) For the management of laboratory waste. (j) For biohazard spills. (k) For cell media and reagent preparation. (l) For quality management of human cells. (m) For the cryopreservation and recovery of cells. (n) For General laboratory use and guidelines. (o) For General tissue and cell processing practices. (p) For infection control. (q) For laboratory cleaning. (r) For the ordering, receipt and storage of chemicals, reagents, consumables. (s) For medical transport to the laboratory. (t) For sample shipping to the medical facility. (u) For environmental monitoring. (v) For personnel training. (w) For decontamination of laboratory facilities. (x) For Response to discrepancy on labeled sample, requisition form, or sample request. (y) For laboratory emergencies. (z) For Incident reporting, corrective and preventive action(s). (aa) For vendor audit scheduling and record retention.

5 (bb) For sterile glove technique. (cc) For the use of Personnel Protective Equipment. (dd) For the use of all required laboratory equipment. (ee) For the maintenance of all required laboratory equipment. Article IV. Staff Roles and Training Section 4.01 Each individual engaged in the conduct of or responsible for the supervision of a laboratory study shall have evidence of competency (i.e., education, training, and experience, or combination thereof) to enable that individual to perform the assigned functions. Section 4.02 The facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. Section 4.03 There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol(s). Section 4.04 There shall be written procedures that personnel take necessary personal sanitation and health precautions designed to avoid contamination of samples and test systems. Section 4.05 Personnel engaged in laboratory activities shall wear clothing appropriate for the duties they perform. Section 4.06 The facility shall provide a written procedure that personnel clearly understand the functions they are to perform. Section 4.07 There shall be written procedures that any individual found at any time to have an illness that may adversely affect the quality and integrity of the laboratory activity be excluded from direct contact with systems.

6 Article V. Supplies Section 5.01 All reagents and solutions in the laboratory areas shall be labeled to indicate identity, concentration, storage requirements, and expiration date. Section 5.02 There shall be a written procedure for the removal of deteriorated or outdated reagents and solutions. Section 5.03 The facility shall provide a written procedure that samples have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.

7 Article VI. Quality Assurance Section 6.01 The testing facility shall have an entirely separate quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. Section 6.02 There shall be a written procedure to bring any problems to the attention of the study director and management immediately. Section 6.03 The quality assurance unit shall maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility. Section 6.04 The quality assurance unit shall maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. Section 6.05 The quality assurance unit shall have a written procedure to inspect each laboratory study at intervals adequate to assure the integrity of the study, including written records of inspection. Section 6.06 The quality assurance unit shall have a written procedure to periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. Section 6.07 The quality assurance unit shall have a written procedure to detail that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Section 6.08 The quality assurance unit shall have a written procedure to review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the laboratory activities. Section 6.09 The quality assurance unit shall have a written procedure to prepare and sign a statement to be included with the final study report which shall specify the dates of inspections were made and findings reported to management and to the study director.

8 Section 6.10 The facility shall provide a written procedure that details that any deviations from regulations are reported by the quality assurance unit. Section 6.11 The facility shall provide a written procedure that reports are communicated to the study director so that corrective actions are taken and documented.

9 Article VII. Sample Management Section 7.01 The facility shall maintain a written procedure to test and document the identity and the stability of each sample article either before study initiation, or concomitantly. Section 7.02 Each sample intended for clinical application shall be marked individually to indicate recipient to ensure that proper identification is maintained throughout the distribution process. Section 7.03 The facility shall maintain a written procedure to test and document the identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch. Section 7.04 The facility shall provide a written procedure for the handling of the samples to ensure that there is proper storage. Section 7.05 The facility shall provide a written procedure for the handling of the samples to ensure that distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage. Section 7.06 The facility shall provide a written procedure for the handling of the samples to ensure that proper identification is maintained throughout the distribution process. Section 7.07 The facility shall provide a written procedure for the handling of the samples to ensure that the receipt and distribution of each batch is documented with date and quantity. Section 7.08 Each sample intended for clinical application shall be marked with an Rx symbol. Section 7.09 To prevent contamination or mix-ups, the facility shall provide separate areas for mixing of the samples. Section 7.10 To prevent contamination or mix-ups, the facility shall provide separate areas for storage of the test and control article mixtures. Section 7.11 To prevent contamination or mix-ups, the areas for storage areas for the test and/or control article and test and control mixture shall be separate from areas housing the test systems to preserve the identity, strength, purity, and stability of the articles and mixtures.

10 Section 7.12 The facility shall maintain a written procedure that each storage container for a test or control article is labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the sample.

11 Article VIII. Data Management Section 8.01 The facility shall maintain a written procedure for the retention of records for a period of at least 2 years. Section 8.02 The facility shall maintain a written procedure that the master schedule sheet, copies of all protocols, and records of quality assurance inspections are maintained by the quality assurance unit as an easily accessible system of records for a period of at least 2 years. Section 8.03 The facility shall maintain a written procedure that summaries of training and experience and job descriptions required are maintained and retained along with all other testing facility employment records for at least 2 years. Section 8.04 The facility shall maintain a written procedure that records and reports of the maintenance and calibration and inspection of equipment are retained for at least 2 years. Section 8.05 There shall be a written procedure that all data, including observations of unanticipated responses of the test system are accurately recorded and verified on forms. Section 8.06 There shall be a written procedure that all unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur. Section 8.07 There shall be a written procedure that all unforeseen circumstances are reported. Section 8.08 There shall be a written procedure that reports of unforeseen circumstances results in corrective action being taken and documented. Section 8.09 There shall be a written procedure that all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. Section 8.10 There shall be sufficient space provided for archives for the storage and retrieval of all raw data and specimens from completed studies. Section 8.11 Storage space shall be limited to access by authorized personnel only.

12 Article IX. Equipment Section 9.01 Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control of shall be appropriate design and adequate capacity to function according to the protocol. Section 9.02 Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be suitably located for operation, inspection, cleaning, and maintenance. Section 9.03 The facility shall maintain a written procedure that equipment is adequately inspected, cleaned, and maintained. Section 9.04 Written procedure shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.

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