FDA GLP Training: Good Laboratory Practice under 21 CFR Part 58

Opens with the question of how we know a new medicine is safe enough to first give to people, and a self-rating on GLP. Covers three FDA cases: a Chinese device testing laboratory whose animals gained exactly half a gram between time points, missed by the study director and quality assurance, in a September 2024 warning letter; an Indian laboratory in December 2025 whose blood samples were centrifuged before they were collected; and a May 2026 letter over dose mixtures never tested. Introduces EFG Bioresearch Laboratories, a contract laboratory in Chicago, and study 24-118, clears four myths, and outlines the thirteen modules in three parts, the four exercises, the final exam and the certificate. It ends with a recap and three practice questions.

What you will be able to do

• Explain why Part 58 exists and what it protects
• Recognise the failures behind recent FDA GLP warning letters
• Describe how the course, exercises and final exam work

Why it matters

Seeing how impossible records reached FDA shows what your own team must catch before an investigator does.

Practice: Practice: Welcome, and why GLP matters · 3 questions

Starts with a medical device company whose Los Angeles testing laboratory sent slides to an outside pathology firm that was never told its reading was part of a GLP study, leaving one phase unsupported. Covers the scope: nonclinical laboratory studies that support, or are intended to support, FDA research or marketing applications. Explains the definitions that matter: testing facility, sponsor, study director, quality assurance unit, test and control articles, test system, and raw data as the worksheets, records and notes needed to reconstruct a study. Shows where Part 58 fits in FDA submissions, that the eCFR text is the rule in force and the 2016 proposal has not been adopted, and why contractors must be told in writing. It ends with a recap and three practice questions.

What you will be able to do

• Decide whether a study falls within the scope of Part 58
• Explain the key Part 58 definitions, including raw data
• Tell a contractor in writing when its work is part of a GLP study

Why it matters

Knowing when GLP applies, and saying so in writing, stops one unsupported phase from weakening a whole study.

Practice: Practice: Part 58: scope and definitions · 3 questions

Opens with findings from two FDA letters: training for a skin reaction test that did not explain how to tell grades of redness and swelling apart, with trainees recording only zeros, and staff who did not record adverse tissue responses or clinical signs. Covers what Part 58 asks of testing facility management: designating the study director, assuring a quality assurance unit, assuring test and control articles are tested, providing resources and acting on quality assurance findings. Explains the personnel requirements: qualified staff with a training summary and job description, enough people for the study, health and appropriate clothing. Shows how EFG plans for study 24-118, and three questions that show management is doing its part. It ends with a recap and three practice questions.

What you will be able to do

• Explain the duties Part 58 gives to testing facility management
• Check personnel records for training, job descriptions and qualifications
• Show that staff clearly understand their functions

Why it matters

Training that really teaches the task, and records that show it, prevent data that only look complete.

Practice: Practice: Management and personnel · 3 questions

Starts with what FDA wrote about study directors: fabricated weight data not identified as improbable in September 2024, and in December 2025 rabbits with no birth dates in breeding records and injection rates and times not recorded. Covers the study director as the single point of study control, with overall responsibility for the study's conduct and results. Explains the six things the study director assures: the protocol, the data, unforeseen events, the test systems, GLP compliance and the archive. Shows what each duty means in practice for study 24-118 at EFG, including a weekly review of data while the study runs, the simplest control and the one FDA most clearly expects. It ends with a recap and three practice questions.

What you will be able to do

• Explain the study director's role as single point of study control
• List the six things the study director must assure
• Review study data while it runs and act on what looks wrong

Why it matters

A study director who reviews data as the study runs catches impossible numbers before they reach a report.

Practice: Practice: The study director: single point of control · 3 questions

Opens with what quality assurance missed in all three FDA letters: a master schedule omitting studies, a final report describing one survival surgery where raw data showed two, and an unauthorised change of airway device. Covers the quality assurance unit as entirely separate from and independent of the people running the study, reporting to management, and its seven duties: keeping the master schedule and protocols, inspecting each study, reporting in writing, checking deviations and reviewing the final report against the raw data. Shows a dosing inspection for 24-118 where a technician nearly draws from the wrong bottle, and the mistake of a format-only report review. In the exercise you plan inspections and draft the QA statement. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Explain how the quality assurance unit stays independent
• Plan quality assurance inspections for a study
• Review a final report against raw data and draft the QA statement

Why it matters

An independent unit that checks reports against raw data finds what a format and spelling review never will.

Practice: Practice: The quality assurance unit · 3 questions

Starts with FDA findings: in May 2026, blood analysis equipment that could not measure the parameters the protocols required, so day 15 haematology and serum chemistry data were never generated, and in September 2024 a scale logged as in use at times that did not match weighing records. Covers what Part 58 requires of facilities: suitable size and construction, separated animal rooms, supply and test article areas, laboratory space and archives. Shows EFG's locked receipt room for test articles and a formulation room used for one study at a time. Explains equipment of appropriate design and capacity, maintained, tested and calibrated under written procedures, records of every check and repair, and a monthly walk-through at a New York academic laboratory. It ends with a recap and three practice questions.

What you will be able to do

• Check that facilities separate activities that could harm a study
• Verify equipment is suitable for the protocol and calibrated
• Record maintenance, calibration and non-routine repairs

Why it matters

Equipment that can do what the protocol needs, and records of its care, stop missing or doubtful data.

Practice: Practice: Facilities and equipment · 3 questions

Opens with FDA's May 2026 finding of no written procedures for handling test articles, observations, laboratory tests, moribund or dead animals or specimen collection, and a December 2025 euthanasia procedure lacking detail. Covers written SOPs for at least the twelve topics Part 58 lists, available where the work is done, with every version kept and deviations authorised by the study director, and EFG's SOP on sampling dose formulations, FOR-006. Explains labelling reagents and solutions with identity, concentration, storage and expiry, and not using them when deteriorated or out of date. Covers animal care: evaluation on arrival, no interfering disease at the start, identification, housing apart where needed, analysed feed and water, and how other animal welfare rules apply alongside Part 58. It ends with a recap and three practice questions.

What you will be able to do

• Check that SOPs cover the topics Part 58 lists
• Label and control reagents and solutions correctly
• Apply Part 58 animal care rules from arrival to study start

Why it matters

Written procedures in place before a study starts are what let your team show the work was done the right way.

Practice: Practice: SOPs, reagents and animal care · 3 questions

Returns to the May 2026 letter, where a facility dosed rats and rabbits with mixtures in sterile water at three levels without testing them for uniformity or concentration first. Covers characterising each batch of test and control article, determining stability before or during the study, labelling and assigning containers, documenting handling by date and quantity, and keeping reserve samples for longer studies. Shows EFG logging every withdrawal of OPQ-117 so amounts can be reconciled, and the dose formulation analysis plan for study 24-118, with every group's concentration checked in weeks one and four within ninety to one hundred and ten per cent and no OPQ-117 in the control. In the exercise you plan formulation analyses and handle a failed result. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Check the characterisation and stability of test articles
• Reconcile article use and keep reserve samples
• Plan dose formulation analyses and handle a failed result

Why it matters

Testing mixtures before dosing means you know each animal received the dose the protocol says.

Practice: Practice: Test and control articles · 3 questions

Returns to the Tianjin laboratory's September 2024 letter, where occlusive dressings in a guinea pig skin sensitisation study fell off, rolled up or were too tight, with no written record. Covers an approved written protocol with its objectives and all its methods, and the study director's signature date as the study initiation date. Explains planned changes amended before they take effect with reasons, signed and dated, and unplanned departures recorded when they occur, assessed and reported. Shows EFG's study calendar built from the protocol and updated the same day as an amendment, quality assurance comparing the deviation log with raw data, specimen identification, and a Dublin sponsor reading every deviation before accepting the report. It ends with a recap and three practice questions.

What you will be able to do

• Check that a protocol contains its objectives and all methods
• Tell a protocol amendment from a deviation and record each
• Conduct and monitor a study as its protocol says

Why it matters

A protocol followed and every departure recorded keeps each result meaningful against the plan.

Practice: Practice: The protocol and the conduct of the study · 3 questions

Returns to the Tianjin case as a raw data problem: animals recorded as gaining exactly half a gram, found because the scale log did not agree with the weight time points. Covers what raw data are under Part 58: the original worksheets, records, memoranda and notes, whatever they are written on, so a weight on a sticky note makes the sticky note the raw data. Explains recording directly, promptly and legibly, dated and signed, changes that never obscure the original and carry a reason, and electronic systems that identify who entered and changed data. Shows how the study director and quality assurance review data for plausibility, consistency and completeness. In the exercise you review raw data and decide what should happen next. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Identify what counts as raw data in a study
• Record and correct data so the original stays visible
• Review data for plausibility, consistency and completeness

Why it matters

Knowing that the first record is the one that counts stops copied or adjusted numbers undermining a study.

Practice: Practice: Raw data and data integrity · 3 questions

Starts with the May 2026 letter to a Saint Paul, Minnesota research centre whose final report did not reflect two rat deaths and gave a wrong day of death. Covers a final report with at least the fourteen items Part 58 lists, telling everything that happened and matching the raw data, signed by the study director, and corrected by amendment. Shows the circumstances in the 24-118 report, including a day 12 room temperature event, a failed mid-dose formulation remade before dosing and late blood samples. Explains archives with a responsible person, restricted access, protective conditions and an index, keeping electronic data readable, and retention: two years after approval, five years after submission, or two years after completion. It ends with a recap and three practice questions.

What you will be able to do

• Check that a final report contains the required items and matches raw data
• Correct a signed final report by amendment
• Apply the Part 58 retention periods to study records

Why it matters

A report that tells everything and an archive you can search mean the study can be checked years later.

Practice: Practice: The final report, archives and retention · 3 questions

Opens with what the three warning letters asked for, including documented corrective and preventive actions within fifteen working days and the possibility of disqualification under section 58.202. Covers a testing facility's duty to let FDA inspect and copy required records and specimens, except quality assurance findings, and that refusal means a study is not considered. Explains Form FDA 483 observations and a response within fifteen business days with causes, corrections, prevention and evidence. Shows how EFG hosts an inspection and logs every copy given. Covers warning letters, rejection of studies and disqualification on three findings, with consequences for studies and sponsors. In the exercise you draft a response to an observation. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Explain FDA's right to inspect a GLP testing facility
• Write a Form FDA 483 response with causes, corrections and evidence
• Describe the grounds and effects of disqualification

Why it matters

Responding to the system behind an observation, with evidence, is what keeps a facility and its studies acceptable to FDA.

Practice: Practice: FDA inspections and disqualification · 3 questions

Opens with the question an FDA investigator asks: can you follow one study from its protocol to its archive? Shows study 24-118 on one screen in five stages: the plan, with a study director named by management and a protocol reviewed by quality assurance, approved by the sponsor OPQ and signed on 2 June; preparation, with OPQ-117 characterised and rats received and checked; conduct, with formulations analysed before dosing and raw data recorded directly; the report; and the archive. Covers the people and records behind each stage, revisits the three FDA cases, gives a road map for your own facility, points to the OECD GLP course for studies outside the United States, and ends with the final exam.

What you will be able to do

• Follow a GLP study through every stage from protocol to archive
• Link each stage to the people and records behind it
• Apply the road map to your own facility's studies

Why it matters

Following one study end to end shows whether your facility could answer an FDA investigator at any time.

Practice: Practice: Putting it together, and the exam · 3 questions