How often do we have to requalify, and how do we keep equipment in a qualified state?

This is United States federal law, read for five product classes: dietary supplements, human food, finished drugs including over-the-counter drugs, infant formula, and cosmetics. Which one you are in decides what the question even means, so that comes first.

If you make a medical device, this article does not reach you. The device quality system requirement is not read here, and nothing on this page describes it. State law, foreign law, your customer’s contract, and any certification scheme you hold are outside this article too. For a large number of readers those are exactly where a requalification interval comes from, and that is worth knowing before you go looking for a federal one.

On this page: Which rule reaches you · Where IQ, OQ and PQ come from · What the law actually times · The one federal re-proving trigger · What the inspection record shows · The pattern underneath it · Four things to check

Which rule reaches you

Qualification vocabulary travels much further than the rules that use it. The paragraphs below set out what each federal rule says about equipment staying proven, in that rule’s own words, with the applicability and exceptions that travel with it.

The federal rule that reaches each product class, and what it says about keeping equipment proven. The clause lists here are drawn from 21 CFR parts 106, 111, 117 and 211 and the cosmetics subchapter of the Act; they are not a complete reading of any part.

If you make	The federal GMP rule	Does it set a requalification interval?
A dietary supplement	21 CFR part 111	No. It asks for routine calibration, inspection or checking, and leaves routine to you
Human food	21 CFR part 117, subpart B	No. It asks for equipment adequately maintained, with no interval named
A finished drug, including an over-the-counter drug	21 CFR part 211	No. It asks that a written program exist and contain schedules, not what those schedules say
An OTC drug where the product and all its ingredients are ordinarily marketed and consumed as human foods	Pending consideration of a proposed exemption, part 211 is not enforced for it and, until further notice, parts 110 and 117 and where applicable parts 113 through 129 are applied instead	No
Infant formula	21 CFR part 106	No interval, but it is the one rule here that names a re-proving trigger
A cosmetic	The cosmetics subchapter of the Act. No good manufacturing practice part is codified in 21 CFR subchapter G	No

Dietary supplements

Part 111 reaches you if you manufacture, package, label, or hold a dietary supplement, including one you manufacture that another person packages or labels, and one imported or offered for import into any State or territory of the United States, the District of Columbia, or Puerto Rico (21 CFR 111.1(a), 111.1(a)(1), 111.1(a)(2)). Read the carve-out to its end before you rely on it: the requirements about holding do not apply if you are holding at a retail establishment for the sole purpose of direct retail sale to individual consumers, and the same clause then says a retail establishment does not include a warehouse or other storage facility for a retailer, or one that sells directly to individual consumers (111.1(b)).

Search all 590 clauses of part 111 for the words installation qualification, operational qualification, or performance qualification and you will not find them. What the part asks for instead is this:

• Equipment and utensils of appropriate design, construction and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained (21 CFR 111.27(a)).
• For automated, mechanical, or electronic equipment you use to manufacture, package, label, or hold a supplement, you must design or select the equipment so that supplement specifications are consistently met; determine the suitability of the equipment by ensuring it is capable of operating satisfactorily within the operating limits required by the process; routinely calibrate, inspect, or check it to ensure proper performance, with your quality control personnel periodically reviewing those calibrations, inspections or checks; establish and use controls so that any changes to the manufacturing, packaging, labeling, holding or other operations are approved by quality control personnel and instituted only by authorized personnel; and establish and use controls to ensure the equipment functions in accordance with its intended use, approved by quality control personnel (111.30(a) through 111.30(e)). That chapeau matters. Section 111.30 reaches automated, mechanical, or electronic equipment. A hand-operated tool is not inside it, and 111.27 is where it sits instead.
• Calibration, and read the structure of the sentence rather than the summary of it. You must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement before first use, and at the frequency specified in writing by the manufacturer of the instrument and control, or at routine intervals or as otherwise necessary to ensure accuracy and precision (111.27(b), 111.27(b)(1), 111.27(b)(2), 111.27(b)(3)). Before first use is not one of the alternatives. It stands, and then one of the other two. Instruments or controls that cannot be adjusted to agree with the reference standard must be repaired or replaced (111.27(c)).
• You must establish and follow written procedures for fulfilling the requirements of that subpart, including written procedures for calibrating instruments and controls, for calibrating, inspecting and checking automated, mechanical and electronic equipment, and for maintaining, cleaning and sanitizing, as necessary, all equipment, utensils and any other contact surfaces used to manufacture, package, label or hold components or dietary supplements. Including is not a closed list, and establish and follow is two duties, not one (111.25(a), 111.25(b), 111.25(c)).
• Records: documentation, in individual equipment logs, of the date of the use, maintenance, cleaning and sanitizing of equipment, unless that documentation is kept with the batch record (111.35(b)(2)); documentation of any calibration each time it is performed, identifying the instrument, the date, the reference standard used including its certification of accuracy and a history of recertification of accuracy, the calibration method with appropriate limits for accuracy and precision, the readings found, the recalibration method and readings if those limits were not met, and the initials of the person who performed the calibration and any recalibration (111.35(b)(3)(i) through 111.35(b)(3)(vii)); written records of calibrations, inspections and checks of automated equipment (111.35(b)(4)); and documentation of the controls you use to ensure the equipment functions in accordance with its intended use (111.35(b)(6)).
• Quality control operations for equipment, instruments and controls must include reviewing and approving all processes for calibrating instruments and controls, periodically reviewing all records for calibration of instruments and controls, periodically reviewing all records for calibrations, inspections and checks of automated, mechanical or electronic equipment, and reviewing and approving controls to ensure that equipment functions in accordance with its intended use (111.117(a) through 111.117(d)).

Put those together and part 111’s answer to keeping equipment in a proven state is a written program, executed, logged, and reviewed by quality control on a schedule you set. The word qualification never appears against equipment anywhere in it.

Human food

Part 117’s equipment requirements live in subpart B, and its exemptions mostly do not reach subpart B. Except as provided by subpart E, subparts C and G do not apply to a qualified facility, and a qualified facility is subject to the modified requirements in section 117.201 instead (21 CFR 117.5(a)); do not apply to activities subject to the fish and fishery products rule or the juice HACCP rule where you are required to comply and are in compliance with them (117.5(b), 117.5(c)); do not apply to a facility with regard to a dietary supplement in compliance with part 111 and the serious adverse event reporting section (117.5(e)); do not apply to activities subject to the produce safety standards (117.5(f)); and do not apply to a facility solely engaged in storing raw agricultural commodities other than fruits and vegetables (117.5(j)). Section 117.5 carries further exemptions we have not listed here; that list is not exhaustive and the section should be read in full. The six above all lift subparts C and G, and the equipment clauses sit in subpart B, so subpart B keeps reaching a facility that holds one of those six. One exemption in the same section runs the other way, and it is the one to check first. Except as provided in the paragraph that follows it, subpart B does not apply to farms as defined in section 1.227, to fishing vessels not subject to the registration requirements of part 1 subpart H, to establishments solely engaged in the holding and/or transportation of one or more raw agricultural commodities, to activities of farm mixed-type facilities that fall within the definition of farm, or to establishments solely engaged in hulling, shelling, drying, packing and/or holding nuts without additional manufacturing or processing such as roasting (117.5(k)(1)). That carve-out is itself carved back: where a farm or farm mixed-type facility dries or dehydrates raw agricultural commodities that are produce as defined in part 112 to create a distinct commodity, subpart B applies to the packaging, packing and holding of the dried commodities (117.5(k)(2)). So the food equipment clauses do not reach every food business, and which side of 117.5(k) you are on is the first thing to settle.

• All plant equipment and utensils used in manufacturing, processing, packing or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination (21 CFR 117.40(a)(1)).
• Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and of adjacent spaces (117.40(a)(3)), and food-contact surfaces must be maintained to protect food from allergen cross-contact and from being contaminated by any source, including unlawful indirect food additives (117.40(a)(6)).
• Instruments and controls used for measuring, regulating or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be accurate and precise and adequately maintained, and adequate in number for their designated uses (117.40(f)).

No interval. No calibration frequency. Not even the word calibration in that section. Accurate, precise, and adequately maintained is the whole of the standard, and what makes it defensible is the program you can show behind it.

Finished drugs, including over-the-counter drugs

Part 211 carries the minimum current good manufacturing practice for preparation of drug products, excluding positron emission tomography drugs and medical gases as defined in section 213.3(b)(12), for administration to humans or animals (21 CFR 211.1(a)). Two conditions travel with that scope and are worth reading before you assume it reaches you. Pending consideration of a proposed exemption published in 1978, the requirements of the part are not enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, those being products which may also fall within the legal definition of drugs by virtue of their intended use, and until further notice parts 110 and 117, and where applicable parts 113 through 129, are applied instead in determining whether those products are made under current good manufacturing practice (211.1(c)). And if you engage in only some of the operations subject to the drug rules and not others, you need only comply with the regulations applicable to the operations you are engaged in (21 CFR 210.2(b)).

• Equipment used in the manufacture, processing, packing or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (211.63).
• Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements (211.67(a)), and written procedures shall be established and followed for cleaning and maintenance (211.67(b)).
• Automatic, mechanical or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily may be used in the manufacture, processing, packing and holding of a drug product; and if such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance, with written records of those calibration checks and inspections maintained (211.68(a)). That is a conditional permission followed by a duty, and it is the closest thing part 211 has to a qualified-state requirement.
• Laboratory controls shall include the calibration of instruments, apparatus, gauges and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met; and instruments not meeting established specifications shall not be used (211.160(b)(4)).
• A written record of major equipment cleaning, maintenance other than routine lubrication and adjustments, and use shall be included in individual equipment logs showing the date, time, product and lot number of each batch processed, with the persons performing and double-checking dating and signing or initialing the log, and entries in chronological order. Where equipment is dedicated to one product, individual logs are not required provided lots follow in numerical order and are manufactured in numerical sequence, and the cleaning, maintenance and use records are then part of the batch record (211.182).

Read 211.160(b)(4) again slowly, because it answers the question directly. The rule requires that a written program exist and that it contain schedules. It does not say what the schedules are. The interval is yours to set and yours to defend.

Infant formula

Each instrument used for measuring, regulating or controlling mixing time and speed, temperature, pressure, moisture, water activity, or other parameter at any point, step or stage where control is necessary to prevent adulteration must be accurate, easily read, properly maintained, and present in sufficient number for its intended use (21 CFR 106.30(d)). Instruments and controls shall be calibrated against a known reference standard at the time of or before first use and thereafter at routine intervals, as specified in writing by the manufacturer of the instrument or control, or as otherwise deemed necessary to ensure accuracy; the known reference standard shall itself be certified for accuracy at the intervals the instrument maker specifies in writing, or at routine intervals otherwise deemed necessary (106.30(d)(1)). Instruments that cannot be adjusted to agree with the reference standard shall be repaired or replaced (106.30(d)(2)), and where a calibration shows a failure to meet a specification at a control point, a written evaluation of all affected product and of any actions needed shall be made (106.30(d)(3)).

Cosmetics

The Act directs the Secretary to establish good manufacturing practices for facilities by regulation, consistent to the extent practicable and appropriate with national and international standards, intended to protect the public health and ensure that cosmetic products are not adulterated (21 U.S.C. 364b(a)). In establishing them the Secretary is to take account of the size and scope of the businesses and the risks posed, provide flexibility practicable for all sizes and types of facility, and include simplified requirements for smaller businesses as appropriate (364b(b)), and the section sets deadlines for a proposed rule and a final rule measured from December 29, 2022 (364b(c)).

That is a duty on the agency, not a duty on you. We read the eCFR on August 18, 2026: subchapter G of 21 CFR, the cosmetics subchapter, contains parts 700, 701, 710, 720 and 740, and no good manufacturing practice part. So there is no federal cosmetic equipment clause to requalify against. What does reach you is the adulteration standard, which treats a cosmetic as adulterated if it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (21 U.S.C. 361(c)).

Two exemptions in the same subchapter are worth knowing. Responsible persons and facility owners and operators whose average gross annual United States sales of cosmetic products over the previous three-year period is less than $1,000,000, adjusted for inflation, and who do not make the products listed in the next subsection, are considered small businesses and are not subject to the good manufacturing practice or the registration and listing sections (21 U.S.C. 364h(a)). That exemption does not apply to anyone making cosmetic products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use, that are injected, that are intended for internal use, or that are intended to alter appearance for more than 24 hours where removal by the consumer is not part of customary or usual use (364h(b)(1) through 364h(b)(4)). Separately, a cosmetic product or facility that is also subject to the drugs and devices subchapter is exempt from sections 364a, 364b, 364c, 364d, 364e(a), 364f and 364g of the same subchapter, which is a wider list than the two named above, except that a facility also making cosmetic products that are not subject to that subchapter is not exempt with respect to those products (21 U.S.C. 364i(a), 364i(b)).

Where IQ, OQ and PQ come from

The vocabulary is real. It is just not federal law for the products above. Among the sources read here it appears in one place: a harmonized guideline for the manufacture of active pharmaceutical ingredients, which treats qualification as a set of activities that may be run separately or together and gives each of the four letters a job. Design qualification asks whether the design proposed for a facility, equipment or system suits the purpose it is meant for. Installation qualification asks whether what was actually installed or modified matches the approved design, the maker’s recommendations, the user requirements, or both. Operational qualification asks whether it performs the way it is supposed to across the whole operating range anticipated for it. Performance qualification asks whether the equipment and its ancillary systems, wired together as they will actually run, do the job effectively and repeatably against the approved process method and specifications (ICH Q7, 12.30). The same guideline asks for installation and operational qualification to show the suitability of computer hardware and software for their assigned tasks (ICH Q7, 5.41).

Mark the standing of that source before you build a program on it. It is a guideline, not a regulation. It was written about active pharmaceutical ingredient manufacture. If you make a supplement, a food or a cosmetic, it is a well-drafted description of somebody else’s practice, and adopting it is a decision rather than an obligation.

ASTM E2500 comes up in the same conversation, so it is worth saying plainly what we can and cannot tell you about it. Its text is not read here, so nothing on this page describes what it says. The federal incorporation-by-reference index, 21,238 entries read on August 4, 2026, contains no entry for ASTM E2500. A consensus standard binds when a regulation incorporates it by reference, when a contract adopts it, or when a certification scheme you claim requires it. Absent one of those, it is a document you may choose to follow.

Certification schemes are where a written requalification duty most often turns up, and it is usually not about equipment. In the dietary supplement good manufacturing practice standard and in the scheme requirement documents behind supplement facility registration audits, requalification appears inside supplier qualification programs, alongside initial qualification and disqualification (NSF/ANSI 455-2, 4.3.2; NSF Dietary Supplements GMP requirements, D.1.1.1). Federal law does the same thing, and the one place part 111 uses the words is buried inside a condition rather than standing on its own. The part tells you to confirm the identity of other components and determine whether other applicable component specifications are met, and says that to do so you must either conduct appropriate tests or examinations, or rely on a certificate of analysis from the supplier of the component you receive, provided that a list of conditions is met. One of those conditions is that your quality control personnel review and approve the documentation setting forth the basis for qualification and re-qualification of any supplier (21 CFR 111.75(a)(2), 111.75(a)(2)(i), 111.75(a)(2)(ii), 111.75(a)(2)(ii)(E)). So it is a proviso hanging off a route you may never have taken, and either way it is about your supplier, not your mixer.

Where the schemes do speak to equipment qualification, they speak about the initial one. The supplement standard treats temperature mapping as something that should be part of initial equipment qualification, while the over-the-counter drug standard in the same family states it as a requirement, and conditions the whole duty on the product: where product storage requires temperature-controlled storage, special equipment or rooms are to be available and qualified, with temperature mapping part of the initial equipment qualification (NSF/ANSI 455-2, 4.5.15.1; NSF/ANSI 455-4, 4.5.18.1). Should and shall are different words and the difference is the point. These are certification scheme requirements. They bind you because you claimed the certification, and for no other reason.

What the law actually times

Take the word requalification out and read what each rule times. Three things, and only three.

• First use. Calibrate before first use, under the supplement rule (21 CFR 111.27(b)(1)), and at the time of or before first use under the infant formula rule (106.30(d)(1)). This one is fixed and it is not negotiable.
• The instrument maker’s written frequency. Named in the supplement rule as one of the two ways to satisfy ongoing calibration (111.27(b)(2)) and in the infant formula rule the same way (106.30(d)(1)). Where a written frequency exists, it is the easiest interval in the file to defend, because you did not invent it.
• Your own written program. Routine intervals or as otherwise necessary under the supplement rule (111.27(b)(3)); routinely, under a written program designed to assure proper performance, for automated equipment under the drug rule (211.68(a)); at suitable intervals in accordance with an established written program containing specific directions, schedules, limits and remedial provisions, for laboratory instruments under the drug rule (211.160(b)(4)); routinely, for automated equipment under the supplement rule, with quality control periodically reviewing it (111.30(c)).

So the honest answer to how often is that the federal rules point back at you and ask to see the schedule you wrote and the evidence you followed it. That is not a loophole. It is a harder question than a fixed interval, because a number you inherited from a template is a number you cannot explain, and the program is the thing that gets read.

The one federal re-proving trigger

One rule in this set names re-proving after a change, and it is the infant formula rule. A system, in that section, means a collection of components including software and hardware organized to accomplish a specific function or set of functions in a specified environment (21 CFR 106.35(a)(3)). All systems shall be designed, installed, tested and maintained in a manner that will ensure they are capable of performing their intended function and of producing or analyzing infant formula in accordance with that subpart and subpart C of the part (21 CFR 106.35(b)); hardware at any point, step or stage where control is necessary shall be routinely inspected and checked according to written procedures, and hardware capable of being calibrated shall be routinely calibrated according to written procedures (106.35(b)(1)); each system shall be validated prior to the release for distribution of any infant formula manufactured using it (106.35(b)(3)); and any system that is modified shall be revalidated following the modification and prior to the release for distribution of any infant formula manufactured using the modified system (106.35(b)(4)).

That rule does not reach a supplement, a food, a cosmetic or an ordinary drug maker. It is worth reading anyway, because it writes down in one sentence the trigger everyone else has to write for themselves: a modification, then re-proving, then release. In part 111 the equivalent gate exists but stops short of naming re-proving. It asks for controls so that any changes to the manufacturing, packaging, labeling, holding or other operations are approved by quality control personnel and instituted only by authorized personnel (21 CFR 111.30(d)). Quality control approves the change. What the change costs you in re-proving is a call your own program has to make.

What the inspection record shows

FDA publishes its inspection observation records. Here is what investigators actually write up on the clauses that hold equipment in a proven state.

FDA inspection observations citing the equipment clauses named above, fiscal years 2009 to 2026. Observations counts the citation rows; inspections counts the distinct inspections those rows sit in.

Clause	What FDA writes	Observations	Inspections
21 CFR 211.67(b)	Drugs. Written procedures for cleaning and maintenance not established or not followed	1,103	1,078
21 CFR 117.40	Food. Equipment and utensils, cited at the section level	1,100	1,100
21 CFR 211.67(a)	Drugs. Equipment not cleaned, maintained, sanitized or sterilized at appropriate intervals	925	925
21 CFR 211.68(a)	Drugs. Routine calibration, inspection or checking not performed to a written program, or records of it not maintained	807	797
21 CFR 211.63	Drugs. Equipment design, size and location	681	681
21 CFR 211.160(b)(4)	Drugs. Calibration at suitable intervals under an established written program	548	532
21 CFR 211.182	Drugs. Equipment cleaning and use log	318	307
21 CFR 117.40(f)	Food. Instruments and controls accurate, precise, adequately maintained, adequate in number	124	124
21 CFR 111.27(b)	Supplements. Instruments and controls not calibrated before first use, at the maker’s written frequency, or at routine intervals	112	112
21 CFR 111.35(b)(2)	Supplements. No documentation of the date of use, maintenance, cleaning and sanitizing of equipment	92	92
21 CFR 111.30(c)	Supplements. Automated, mechanical or electronic equipment not routinely calibrated, inspected or checked	85	84
21 CFR 111.30(e)	Supplements. No controls established to ensure equipment functions in accordance with its intended use	26	26

Two things stand out once the numbers are on the page. The first is that the drug clauses most often cited are not the qualification-sounding ones. They are cleaning, maintenance, and the written procedure behind them. The second is that the supplement clause cited most often, 111.27(b), is the calibration frequency clause, and the standard text of those observations tracks the rule’s own alternatives word for word: not calibrated before first use, or not calibrated at the frequency specified in writing by the manufacturer or at routine intervals.

What these figures do not evidence. They are counts of citation rows and of the distinct inspections those rows sit in. They are not rates and they have no denominator: no count of firms, and no count of inspections where nothing was written. Not one of these clauses uses the word requalification, so a citation under any of them is evidence that a calibration, a record, a procedure, or a maintenance activity was found wanting, and is not evidence that a qualification had expired. The supplement and food figures being smaller than the drug figures is not evidence that supplement or food equipment is in better condition; the drug part simply carries more equipment clauses to cite, and different inspection programs cite different clause sets. Counted from FDA’s published inspection observation records, read August 18, 2026; fiscal year 2026 was still open at that date, and part 111 citations under 111.35(b)(2) in the record as read stop at fiscal 2023. The record is FDA’s alone, and holds no state, foreign, or certification body findings. The clause selection is ours.

The pattern underneath it

The failure behind this question is not that somebody forgot a date. It is whether the alteration was recognized as an alteration at all.

In the failures we have seen, what counts as a modification requiring formal control runs past plant and equipment to procedures, people and substances; and taking a working part or subsystem out of service is itself a modification, after which the thing sits outside a condition its design assumed, and that departure can contribute to a later failure. Mark the weight of that: each rests on a single account, and the first is stated as good practice rather than as an observation of what firms actually do.

The second pattern is what happens to the paperwork while that goes on. The record and the thing it describes come apart as the thing changes. Documents go stale, physical changes get made and never written back, and an index can report something that no longer exists. That one is contested rather than settled: some hold it is a lag to be closed, others that it is permanent, a record attesting only to a past state and going out of date at exactly the rate the thing changes. How much harm traces to the stale record is disputed too.

What follows is our own position rather than anything the clauses above require. A qualification package that survives a hard question names its own triggers on its own face: what change to this equipment, this process, or this product would make the conclusion in this report no longer true, and who decides. No clause cited here demands that page. It is the shortest document we know of that answers the question when it is put across a table, and it is what turns an interval into a defensible one. When an audit or a 483 demands the whole package, what has to be in it is the next question.

The Bro Science constructed case works the same failure from the other end: a fill room described as certified with no test behind the word, and a qualification with nothing keeping it current. It is a constructed teaching example, not a real company. If the neighboring question you have is about the process rather than the machine, the piece on how many PPQ batches are actually required reads the same way about run counts. Keeping that process proven afterwards, and reacting to what the data shows, is continued process verification.

Four things to check

1. Find the sentence that sets your interval, and read what sits after it. If the reason is that annual is standard, that is the sentence to rewrite. If there is no reason at all, that is a finding you would rather make yourself.
2. Look up the instrument maker’s written frequency. Under the supplement and infant formula rules it is one of the named ways to satisfy ongoing calibration. It costs nothing to use and it is the interval you never have to justify from scratch.
3. List every change made to that equipment in the past year and ask which ones were treated as changes. A relocation, a replaced part, a different product on the same line, a new cleaning agent, a changed operating range. The ones nobody called a change are the ones your program never saw.
4. Open the equipment log. Under the supplement rule you must keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning and sanitizing of equipment, unless that documentation is kept with the batch record. Under the drug rule the log shall show the date, time, product and lot number of each batch processed, dated and signed or initialed by the persons performing and double-checking the cleaning and maintenance, in chronological order.