Working under GMP

Why it matters

Medicines, vaccines and many biological products must be made under Good Manufacturing Practice (GMP): rules that make sure every batch is made the same validated way, by trained people, with a complete record. A patient cannot test their own medicine, so the record is the evidence. For many biological technicians, GMP is the daily working environment, and the basic skill is executing a batch record correctly. As the saying goes: if it is not documented, it did not happen.

What GMP covers

GMP regulations and guidelines cover, among other things:

• Personnel: qualified, trained people with training records for every procedure they perform.
• Facilities and equipment: designed, qualified, cleaned and maintained (next lesson).
• Materials: approved suppliers, identity testing, quarantine until release, traceable lot numbers.
• Procedures: written, approved SOPs and batch records, followed exactly.
• Records: complete, accurate, contemporaneous, reviewed.
• Quality unit: an independent quality assurance (QA) function that approves procedures and releases or rejects batches.
• Deviations, CAPA and change control: anything unplanned is recorded and investigated; changes are assessed before they are made.

In the US, the core drug GMP regulations are 21 CFR Parts 210 and 211, with additional requirements for biologics in Parts 600 to 680. FDA's overview: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations (Checked on 2026-10-23.) In the EU, EudraLex Volume 4 sets GMP: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en (Checked on 2026-10-23.) Other regions follow similar rules, often harmonised through PIC/S and ICH.

The batch record

A master batch record is the approved template for making one batch of a product: materials and quantities, equipment, step-by-step instructions, process parameters and limits, sampling, and signature fields. For each batch, a controlled copy is issued and becomes the executed batch record as operators fill it in.

Executing a step typically means:

1. Read the step before doing it.
2. Do exactly what it says, with the equipment and materials it names.
3. Record the actual values (weights, times, temperatures, lot numbers, equipment IDs) at the time, in permanent ink or the electronic system.
4. Sign and date ("performed by").
5. A second trained person verifies critical steps (such as weighing or adding an ingredient) and signs "verified by".

Good documentation practice (GDP)

GDP applies the ALCOA+ principles you learned in the lab data course:

• Write entries at the time, never from memory later, and never pre-fill.
• Record actual values with units, not "OK" or a tick where a number is required.
• Correct errors with a single line, the correct value, initials, date and a reason. No correction fluid, no overwriting.
• Never leave blanks: write "N/A" with initials if a field does not apply, as your procedure allows.
• Use your own signature or login; never sign for someone else.
• If something goes differently from the instruction, stop and record a deviation following your SOP, and tell your supervisor. Do not improvise and carry on.

Worked example. Step 12 says "Add 25.0 kg (24.8 to 25.2 kg) of buffer component X, lot to be recorded. Verify." You weigh 25.1 kg, record "25.1 kg", the lot number, the balance ID, the time, sign "performed by", and a colleague who watched the weighing signs "verified by". If you had weighed 25.4 kg, you would not just record it and continue: it is outside the range, so you stop and follow the deviation procedure.

After the batch

QA reviews the executed batch record, along with test results, deviations and environmental data, before the batch can be released. Any gap (a missing signature, an unexplained correction) delays release and can trigger an investigation. You will review batch data yourself in this module's last lesson.

Training reality

GMP training is given by the employer, specific to its procedures, and repeated regularly. Many community colleges and universities offer biomanufacturing certificates with GMP and aseptic modules. You do not work unsupervised in a GMP area until you are trained and qualified on that procedure.

Common mistakes

• Filling in several steps at once at the end of the shift.
• Writing a value outside the range and carrying on.
• Ticking "verified" without watching the step.
• Using a stray piece of paper as a "rough record".
• Unsigned or undated corrections.

Quick recap

• GMP: trained people, qualified equipment, controlled materials, written procedures, complete records, independent QA.
• Master batch record (template) vs executed batch record (this batch).
• Read, do, record actual values, sign, verify critical steps.
• GDP: contemporaneous, single-line corrections with reason, no blanks, no signing for others, stop and record deviations.

Try it

Open the Do tab to write and execute a mock batch record for a kitchen-safe sugar solution.