Most life sciences manufacturers that run into troubleduring an inspection already have the programs that pharmaceutical EHScompliance calls for. There is a hazard communication plan, a waste contingencyplan and a corrective action procedure.
The finding tends to land somewhere else: in the step wherea record should have changed and didn't, because the work passed from one teamto another and nobody owned the handoff.
An EHS gap in pharmaceuticals is the distance between what asite's procedures require and what its records can show on the day someoneasks. The four gaps below turn up again and again in OSHA citation data, EPAsettlements and FDA observations, and each one starts as an ordinary workflowproblem.
1. Safety data sheets for in-house APIs and intermediates
Hazard Communication was the second most cited OSHA standardin fiscal year 2026, with 1,961 violations recorded between October 1, 2025 andAugust 31, 2026, according to preliminary figures released with the NationalSafety Council in September 2026. Most of those citations go to ordinaryemployers with missing labels or thin training records.
Drug manufacturers carry an extra duty on top of that. Under29 CFR 1910.1200(g)(1), a chemical manufacturer has to author a safety datasheet (SDS) for each hazardous chemical it produces, which is usually done by SDScreation software.
This EHS gap in pharmaceutical manufacturing comes from asplit in ownership between the data and the document. Toxicology andoccupational exposure band data for a new compound sit with development, whilethe SDS sits with EHS or regulatory affairs.
When a new study changes the hazard picture, the SDS oftenstays as it was, even though the standard gives the preparer three months toadd significant new hazard information once they become aware of it.
OSHA's 2024 update to the standard, with the four-monthextension announced in January 2026, set these compliance dates:
Who must comply
Substances
Mixtures
Manufacturers, importers and distributors (SDSs and labels)
May 19, 2026
November 19, 2027
Employers (workplace labels, written program, training)
November 20, 2026
May 19, 2028
The substance deadline for manufacturers has already passed.Any in-house compound still on an SDS written to the old format is out of dateunder the rule. Some manufacturers now run SDS Authoring in-house, generatingthe document from the same composition and hazard data the process teammaintains, so the two records can't drift apart.
2. Hazardous waste records that lag behind the process
EPA's June 9, 2026 settlement with Nitto Denko Avecia showshow waste gaps build up at a working drug manufacturing site. The companyagreed to pay $858,889 to resolve federal RCRA and Massachusetts hazardouswaste violations at two facilities in Milford, Massachusetts. EPA's list ofproblems covered five areas:
- Hazardous waste air emissions.
- Design and installation of hazardous waste tank systems.
- Equipment inspections.
- Labeling of waste and storage areas.
- Contingency planning.
None of these is exotic. The corrective measures the companyput in place, including a leak detection program, daily tank inspections, andupdated emergency response plans, are routine tasks for any site that generateshazardous waste.
There is a structural reason these tasks slip. Waste streamschange every time a process is scaled up, a solvent is swapped, or a newproduct goes into a suite. The waste determination, the tank inspection log,and the contingency plan rarely sit in the same change request as the processupdate, so they fall behind by one revision, then two.
3. Corrective actions closed without an effectiveness check
Corrective action is where EHS and quality systems look mostalike, and it is where EHS programs tend to be weaker. ISO 45001, theoccupational health and safety standard many manufacturers certify to, requiresan organization to review the effectiveness of any corrective action it takes.Also, it requires keeping documented information on the results, includingwhether the action worked.
Many EHS teams track the action and close it when the taskis done. The guard goes on, the procedure is revised, the training is delivered.Nobody comes back 60 or 90 days later to confirm the original hazard is gone.
FDA observations show how regulators treat the same patternon the quality side. Citations under 21 CFR 211.192, the production recordreview rule that requires investigation of unexplained discrepancies, rose 171% from 2023 to 2024 in Form 483 observationsissued to sterile drug manufacturers, according to an analysis published byPharmaceutical Online.
The EHS version of that finding is a repeat incident at aworkstation that already has a closed corrective action against it. The recordshows the investigation stopped at a symptom.
The fix is mostly about where the follow-up lives. EHS CAPA Management Software can hold theeffectiveness check as a dated, assigned task, so the action can't be markedclosed until someone confirms the fix held. A spreadsheet can do the same inprinciple, though the follow-up column is usually the one left blank.
4. Process changes that skip EHS review
Scale-up, technology transfer and new equipment introducemore new hazards in a shorter time than anything else a drug manufacturing sitedoes. ISO 45001 clause 8.1.3 requires a process for implementing andcontrolling planned temporary and permanent changes that affect health andsafety performance.
Most GMP change control systems already route changes toquality, regulatory, and validation reviewers. EHS is often an optionalreviewer, or gets copied at the end.
The consequences are visible in OSHA's fiscal 2026 list.Lockout/Tagout ranked third with 1,863 violations and Respiratory Protectionsixth with 1,608. A process change touches both directly.
New equipment needs its own energy control procedure, and acompound with a lower exposure band can move an operation from local exhaustventilation to respirator use, which brings fit testing and medical evaluationwith it.
Making EHS a required approver on change controls, with ashort checklist covering new chemicals, new energy sources, new waste streams,and changed exposure levels, is a small addition to a process most sitesalready run, and it closes one of the more common EHS gaps in pharmaceuticalmanufacturing.
Closing the EHS gap in pharmaceuticals before the next inspection
Each gap above sits between two teams: development and EHSfor safety data sheets, operations and EHS for waste, quality and EHS forcorrective actions and change control.
Companies that publish their EHS approach tend to describeit as a single system. Alkermes, for example, describes a program built on an enterprise-wide risk management framework andaligned with ISO 14001 and ISO 45001.
A practical place to start is one recent process change,traced end to end. Check whether the SDS, the waste determination, the energycontrol procedure, and any related corrective action all updated with it. Whereone didn't, the gap is already on record.