Active substances: what the rules ask.

What the rules ask, and what is built.

EU GMP Part II · EU GMP Annex 1. 26 of 91 record types kept in MALUTI · 65 not built yet.

A record type in our catalogue is one thing a clause asks a site to record. Each is counted once, even when two documents or a step of the path ask for it. “Kept in MALUTI” covers what MALUTI does itself and the record it keeps of work your site does. The count shows what we have mapped, not a share of the regulation.

Not built yet (65)

• Take the daily statement that bars a person from the clean room, and act on it EU GMP Annex 1 §7.7, §7.8
• Hold the written description of how a machine is built, and keep it current EU GMP Annex 1 §5.1
• Keep the installation record of each utility system for its whole life: drawings, materials, specification EU GMP Annex 1 §6.5
• For a bulk delivery in a non-dedicated tanker, hold the assurance that it arrived clean EU GMP Part II 7.22
• Record why a material was accepted on its certificate alone, without a test of our own EU GMP Part II 7.32
• Use the oldest stock first EU GMP Part II 7.42
• Re-evaluate material after long storage EU GMP Part II 7.50
• Record who took material out of store for a run EU GMP Part II 6.3
• Reprocess or rework, after investigating why EU GMP Part II 14.2–14.3
• Blend only batches that passed, trace the blend to each of them, and date it by the oldest EU GMP Part II 8.41, 8.44, 8.47
• Record what was recovered — solvent, mother liquor — and the testing that let it back into the process EU GMP Part II 14.40–14.43
• Record a contamination event in a culture, identify what grew, and let it decide the fate of the material EU GMP Part II 18.36, 18.37
• Hold the impurity profile of the substance, and compare it against the registered one at intervals EU GMP Part II 11.21, 11.22
• Give the substance a retest date from its stability data, and retest it before that date passes EU GMP Part II 11.61, 11.63
• When we repack or resell someone else's substance, keep the chain back to the original manufacturer and name them to the buyer EU GMP Part II 17.20, 17.61
• Hold records for the required years EU GMP Part II 6.13
• Qualify a person for aseptic gowning, and reassess at least annually EU GMP Annex 1 §7.4
• Disqualify a person from the clean room, and let them back only through requalification EU GMP Annex 1 §7.6
• Qualify each operator who inspects filled containers, at least annually and with an eyesight check EU GMP Annex 1 §8.31
• Declare how many people a clean room may hold at once, and keep to that number EU GMP Annex 1 §7.2
• Let an unqualified person into grade A or B only as a recorded exception, under a named supervisor EU GMP Annex 1 §7.5
• Acknowledge every process and equipment alarm, and trend them; critical ones are looked at at once EU GMP Annex 1 §5.2
• Approve a machine back into use after maintenance, and assess what unplanned work did to sterility EU GMP Annex 1 §5.6, §5.7
• Qualify a clean room and requalify it before its interval runs out EU GMP Annex 1 §4.25, §4.32
• Disinfect clean rooms to a written programme, and validate it EU GMP Annex 1 §4.33, §4.34
• Run the environmental monitoring programme, with an alert level below the action limit EU GMP Annex 1 §9.4, §9.9
• Investigate an exceeded action limit and name the batches it touched EU GMP Annex 1 §9.13
• Sample the water system on a plan, and investigate its excursions EU GMP Annex 1 §6.13, §6.14
• Trend the environmental results by the patterns the annex names, including a change in the flora itself EU GMP Annex 1 §9.11
• Monitor grade A without a break for the whole of critical processing, and raise an alarm at the alert level EU GMP Annex 1 §9.16, §9.17, §9.24
• Sample gloves and gown after every critical intervention and on each exit from grade B EU GMP Annex 1 §9.25, §9.26
• Identify what grew in grade A or B down to the species, and judge what it means for each batch implicated EU GMP Annex 1 §9.31
• Hold the approved list of what may be taken into grade A and B, and record every exception to it EU GMP Annex 1 §4.12
• Hold the airflow visualisation studies, at rest and in operation, with the recordings they produced EU GMP Annex 1 §4.15
• Record the air pressure differences between rooms, and record what was decided when the warning fired EU GMP Annex 1 §4.16
• Run the barrier bio-decontamination cycle inside its validated parameters, and record each run EU GMP Annex 1 §4.22
• Hold the clean-up period the room was qualified with, and do not call the room clean before it has passed EU GMP Annex 1 §4.29
• Trend the critical parameters of every high-risk utility, not only its excursions EU GMP Annex 1 §6.4
• Sanitise the water system on its schedule, and hold every batch made on that water until its results are approved EU GMP Annex 1 §6.12
• Hold the quality of every process gas, and monitor it microbially at the point of use EU GMP Annex 1 §6.18, §6.19
• Keep the contamination control strategy, and review it EU GMP Annex 1 §2.3, §2.6
• Hold the authorised list of interventions, and record each one in the batch record with its time, duration and operator EU GMP Annex 1 §8.16, §8.17
• Hold each stage of aseptic processing inside its declared maximum time EU GMP Annex 1 §8.18
• Tell what has been through the steriliser from what has not EU GMP Annex 1 §8.44
• Record every sterilisation run under its own identifier, and approve it at release EU GMP Annex 1 §8.45
• Validate the sterilisation loads, and revalidate them on schedule EU GMP Annex 1 §8.36, §8.38, §8.39
• Test the sterilising filter before use and after use, and keep both results with the batch EU GMP Annex 1 §8.87
• Take bioburden from the bulk immediately before the final filter, against a declared limit EU GMP Annex 1 §8.93, §10.3
• Inspect every filled container, and trend the defects found EU GMP Annex 1 §8.30, §8.33
• Run the aseptic process simulation on its schedule, and document it with a reconciliation of units EU GMP Annex 1 §9.38, §9.47
• On a failed simulation, quarantine what the line made since the last good one EU GMP Annex 1 §9.46
• Have aseptic operations watched by someone expert in them, on a regular basis, and act on what is seen EU GMP Annex 1 §8.19
• Test container closure integrity — every fused container, a justified sample of the others EU GMP Annex 1 §8.22, §8.23, §8.24
• Challenge the automated inspection machine with known defects before start-up and during the batch EU GMP Annex 1 §8.32
• Detect a sterilisation cycle that left its validated parameters, and investigate it EU GMP Annex 1 §8.35, §8.41
• Run a positive control for every cycle that uses biological indicators, and verify each new indicator batch before use EU GMP Annex 1 §8.42, §8.43
• Inspect each item leaving the steriliser for dryness, damage and packaging integrity, and investigate what fails EU GMP Annex 1 §8.56, §8.57
• Put the filtration parameters into the batch record, and investigate a run that differs from them EU GMP Annex 1 §8.86
• Test critical gas and vent filters after use, record the others at intervals, and hold their maximum duration of use EU GMP Annex 1 §8.88, §8.89
• Discard a sterilising filter after one batch, or hold a validated campaign duration and refuse to pass it EU GMP Annex 1 §8.94, §8.95
• Sterilise the lyophiliser on its justified frequency, and check its leak rate at the start of every cycle EU GMP Annex 1 §8.122, §8.124
• Record the critical parameters of each form-fill-seal or blow-fill-seal run, and investigate rejected units EU GMP Annex 1 §8.102, §8.103, §8.116, §8.117
• Incubate every integral simulation unit, justify each one not incubated, and have them read by a qualified person against a positive control EU GMP Annex 1 §9.41, §9.43, §9.44, §9.45
• Justify in writing which batches an investigation covers, and close it before the batch is certified EU GMP Annex 1 §3.2
• Review the environmental data of the time of manufacture, and its trend, as part of releasing the batch EU GMP Annex 1 §10.10

Built in MALUTI (26)ShowHide

• Calibrate instruments against a schedule EU GMP Part II 5.30–5.35
• Keep the use and cleaning log of each machine EU GMP Part II 6.20
• Run preventative maintenance to a schedule, with someone named for each machine EU GMP Part II 5.20
• Examine each container: labels, damage, broken seals EU GMP Part II 7.20
• Run an identity test on every batch received EU GMP Part II 7.30
• Judge how far a supplier certificate can be trusted EU GMP Part II 7.31
• Re-check supplier certificates at the interval this site declares EU GMP Part II 7.31
• Hold seed lots and cell banks as master and working generations, and count the passages between them and the product EU GMP Part II 18.22
• Keep reference and retention samples EU GMP Part II 11.71
• Run an on-going stability programme EU GMP Part II 11.54
• Record a complaint from outside: who complained, what was answered, and what happened to the batch EU GMP Part II 15.10–15.12
• Run formal change control EU GMP Part II 13, Annex 15 §11
• Clear the line before packing, and record it EU GMP Part II 9.44
• Issue, reconcile and destroy labels EU GMP Part II 9.30–9.33
• Seal so the receiver is alerted to tampering EU GMP Part II 9.46
• Record a batch that came back: from whom, how much, why, and what was done with it EU GMP Part II 14.50–14.52
• Record and investigate an incident of the system itself, and say what it did to the records made at that time EU GMP Part II 5.46
• Test the barrier glove system for leaks at the start and end of each batch, and look at it at every use EU GMP Annex 1 §4.21
• Hold each clean room garment as an item: its sterilisation, its hold time, its laundry count and the point it is replaced EU GMP Annex 1 §7.11, §7.15, §7.17
• Hold each disinfectant as a batch: sterile for grade A and B, dilutions monitored and given an expiry EU GMP Annex 1 §4.35
• Test pure steam on a schedule — condensate to the monograph, plus non-condensable gases, dryness and superheat EU GMP Annex 1 §6.17
• Check the sterile barrier of each sterilised item before use, and hold the shelf life its packaging was validated for EU GMP Annex 1 §8.48
• Run the steriliser leak test weekly and the air removal test daily, and keep both results EU GMP Annex 1 §8.60, §8.61
• Check each single-use system on receipt against its specification and its proof of sterilisation EU GMP Annex 1 §8.134, §8.138
• Take a sample to a sampling plan EU GMP Annex 1 §10.6
• Test each batch of medium for growth promotion before it is used, and justify any reliance on the supplier EU GMP Annex 1 §10.9