Table 1.

Procedures and control measures taken to ensure compliance with the Orange Guide and MHRA licencing.

	FMT production facility	FMT donor screening	FMT preparation	FMT supply
Product quality assurance	Dedicated manufacturing facility Equipment IQ/PQ/OQ1 Environment and equipment temperature monitoring Equipment calibration, maintenance and verification Prospective equipment performance monitoring Controlled facility access Integration into a Quality Management System	Standardised donor screening UKAS (or equivalent) accredited microbiological testing Independent clinical assessment of donors Regular review of donor screening policy Use of written document controlled SOPs	Defined donation acceptance criteria (based on visual, consistency and storage time criteria) Consumable supplier validation to establish suitability of consumables Use of written document controlled SOPs Batch release from quarantine by Qualified Person Standardised training and competency assessment of personnel FMT Reference sample storage	Validation of transport procedures to maintain appropriate storage conditions during transport Detailed instruction for storage and use, with specified expiry date Thawing and re-freezing prohibited Competent transport couriers
Cross contamination minimisation	Validation of cleaning methodology Environmental monitoring for enteric indicator organisms, with comparison to Grade D clean room recommended limits Exclusion of materials from the facility which can support microbial growth	Standard collection protocol utilising sterile containers Specified expiry timescales for storage	Single batch production2 Single use consumables and excipients Closed filtering and homogenisation Operator personal protective equipment (laboratory coat, gloves, hair net, mask and overshoes) Production within a Class 2 microbiological safety cabinet Direct transfer of filtrate from sterile filer bag into primary container	Packaging compliant with P650 packing Instruction for biological specimens
Traceability	Use of electronic specimen tracking system for donations, batches, lots and reference samples within the FMT facility	Unique anonymous Donor Identifiers	Batch processing records3 Unique and traceable batch and lot numbering	Supply on named patient basis only Standardised electronic requesting Validation certificate supplied with every FMT for retention in the patients notes4 Product labelling compliant with British Pharmacopoeia 2017 general monograph for unlicensed medicines

¹IQ/PQ/OQ: installation qualification, performance qualification, operating qualification.

²Batch of FMT defined as all lots prepared from a single faeces donation from an individual donor.

³Batch processing records recorded date and time of stool production, unique donor identification number, donation macroscopic appearance, consumable and excipient lot numbers and expiry dates, weight of donor stool used, volume of saline used, volume of glycerol used, date and time of production, unique batch and lot numbers and operator name.

⁴The validation certificate documents unique treatment identification numbers, source of FMT and production location, storage instructions, and statement confirming donor screening testing acceptability.