Good Manufacturing Practice
The rules that make a batch releasable: documented at the time of performance, reviewed by the quality unit, investigated when the numbers do not agree.
Good manufacturing practice is the body of regulation governing how a product is made, controlled, and documented. In the United States, 21 CFR Parts 210 and 211 set current GMP for finished pharmaceuticals: each significant step is documented at the time it is performed, and the quality control unit reviews the batch record before release.
Requirements covering facilities, equipment, personnel, process control, and the master and batch records that prove a product was made as intended.
US Food and Drug Administration, and equivalent regulators worldwide
Manufacturers of finished pharmaceuticals and APIs. 21 CFR Parts 210 and 211.
Not a certificate. FDA assesses conformance through inspection; findings arrive as observations or warning letters.
Manufacturers of drugs, dietary supplements, cosmetics, and medical products, including contract manufacturers.
| Requirement | Module | What It Does |
|---|---|---|
| Batch data captured at the step, not after it | Production | Section 211.100(b) requires written production and process control procedures to be followed and documented at the time of performance, with any deviation recorded and justified. WorkCell has operators record quantities, scrap, and time at the operation, and inspection results against the characteristic checked, so the data accumulates while the work happens instead of being reconstructed at shift end. It is not a validated electronic batch record, and the master production record and its instructions live elsewhere. |
| Component lots, quantities, and the batch they entered | Inventory | Section 211.188 wants specific identification of each batch of component or in-process material used, and the weights and measures of components used in the course of processing. WorkCell receives material against a lot, carries that lot through every issue to the work order, and tracks quantity in pieces and in the unit of measure the item is held in. The identity test 211.84 requires on each component lot happens in your laboratory, and recording its result is yours. |
| Material that cannot move until it is released | Inventory | Sections 211.84 and 211.165 both turn on material not moving until it has been approved for use or for distribution. WorkCell holds QC states on inventory, so a lot under test or rejected cannot be issued to a batch because the floor was behind schedule. The control sits in the system rather than on a quarantine tag taped to a tote. Setting the specifications and making the release decision stay with your quality control unit. |
| Discrepancy and investigation records | Quality | Section 211.192 requires any unexplained discrepancy, including a percentage of theoretical yield outside the range in the master record, or any failure of a batch or component to meet specification, to be thoroughly investigated whether or not the batch has already been distributed. WorkCell raises severity-classified nonconformances and runs 8-D corrective action against the job, the lot, and the part, so the investigation, its disposition and the quality unit's closure sit on the batch they belong to, dated from discovery through verification. |
| Actual yield reconciled from the transactions | Analytics | Section 211.188 asks for a statement of actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing. WorkCell knows what was issued to the work order and what was completed off it, so issued against produced reconciles from the records themselves rather than from a calculator and a clipboard. Every posting is stamped with a cost object, which is how a yield loss turns into a number somebody can act on. |
| Who performed each step, and when | Workforce | Section 211.188 requires identification of the persons performing and directly supervising or checking each significant step in the operation, and 211.182 requires the equipment cleaning and use log to be signed and dated in chronological order. WorkCell stamps the actor and the timestamp on every transaction and enforces permissions by role. It holds no equipment cleaning log, no training records, and no electronic signature, so those three stay on paper or in another system. |
The investigator chooses a lot and reads its record end to end. Section 211.188 expects an accurate reproduction of the appropriate master production or control record, checked for accuracy, dated and signed, plus documentation that each significant step was accomplished: dates, the identity of individual major equipment and lines used, each component batch and its weights and measures, in-process and laboratory control results, inspection of the packaging and labeling area, actual and percentage of theoretical yield, labeling control records, sampling performed, and the person on each step.
Section 211.192 puts the review and approval of all drug product production and control records, packaging and labeling included, with the quality control unit, to determine compliance with established approved written procedures before a batch is released or distributed. The record the investigator wants is the dated approval itself, bound to the batch it released. WorkCell holds the production and control record the quality control unit reviews, with the QC state on the lot deciding whether it can move, so the approval and the evidence behind it resolve to one lot rather than two filing systems.
When a yield falls outside the range in the master record or a result misses specification, 211.192 wants a thorough investigation that extends to other batches of the same product and other products that may have been associated with the failure, and a written record including the conclusions and followup. Closing an investigation with a plausible cause and no extension to neighboring batches is one of the most common observations written against this section.
Section 211.182 asks for a written record per major piece of equipment showing cleaning, maintenance, and use, including the date, time, product, and lot number of each batch processed, signed and dated by the person performing or verifying the work in chronological order. This is not in WorkCell. It is a routinely cited gap across the industry, so keep it deliberately in whatever system or logbook you choose rather than discovering the hole during an inspection.
Section 211.180 keeps production, control, and distribution records for at least one year after the expiration date of the batch, or three years after distribution for an OTC drug product without expiration dating, and requires them readily available for authorized inspection. Where any of those records are electronic, Part 11 attaches and your own validation has to cover the systems holding them, including whatever you do when a system or a vendor changes.
What is the difference between GMP and cGMP?
The c stands for current, and that is the whole point of the term. FDA uses cGMP to signal that the expectation moves with available technology and prevailing industry practice, so a system an investigator accepted a decade ago can be found inadequate now. The regulation text itself is 21 CFR Parts 210 and 211.
Does cGMP require an electronic batch record?
No. Section 211.188 requires a batch production and control record; it does not prescribe a medium. Paper remains lawful and common. If you choose electronic, Part 11 attaches and you carry the validation burden for the system holding it, against your own intended use and configuration. WorkCell supports that protocol with documented system behavior, configuration detail and completed supplier questionnaires.
What is the quality control unit, and can it report into production?
It is the unit holding authority under 211.22 to approve or reject components, in-process materials, packaging, labeling, and finished product, and to review production records. Adequate laboratory facilities must be available to it. FDA reads the section as requiring independence from production, so a quality head reporting to operations invites a finding.
Does WorkCell make us GMP compliant?
No. No software confers compliance. cGMP covers your facility, equipment, personnel, procedures, laboratory, and quality unit, and an investigator inspects all of it. WorkCell captures production, inventory, and traceability records that cGMP asks you to keep. It is not validated, not certified, and several required cGMP records are simply not in it.
How long do we have to keep batch records?
Under 211.180, at least one year after the expiration date of the batch, and for an OTC drug product without expiration dating, three years after distribution. They must stay readily available for authorized inspection. Electronic copies have to remain accurately and readily retrievable for that whole period, which is a Part 11 requirement as well.
Which cGMP records does WorkCell hold?
The batch production and control record and the transactions behind it: the components issued with their lots, the yield against the master record, the in-process and finished acceptance results against the characteristics checked, the QC state that decides whether a lot can move, the investigations under 211.192 with their disposition and corrective action, the equipment the batch ran on, and the person and time on every entry. Each one is attributable as it is created rather than reconstructed for an inspection.
Keep the records as the work happens.
Tell us how your batch records get built and reviewed today and we will tell you straight which cGMP records WorkCell would carry and which ones it would not.