EDQM has released Pharmeuropa 38.3 for public consultation, with comments open until 30 September 2026. The issue includes 40 draft texts, including several proposed revisions that may affect QC microbiology, herbal product testing, specifications, and internal pharmacopoeial references.
These drafts are not yet official standards, but once adopted, Ph. Eur. monographs become legally binding in Ph. Eur. member states. General texts may also become mandatory when referenced in a monograph.
Five of the forty drafts are close to the daily work of non-sterile and herbal-quality professionals. Three of them form a single coordinated package, one is a substantial technical overhaul, and one is a short but useful clarification. Here is what changed, and where it lands.
| Ph. Eur. text | Proposed change | Practical GMP impact |
|---|---|---|
| 2.6.12 Microbial enumeration tests | Sample preparation, sampling quantity, and membrane filtration instructions have been updated to include cutaneous patches and medicated plasters. | QC microbiology methods, sample preparation instructions, suitability studies, and laboratory worksheets may need to be revised for these dosage forms. |
| 2.6.13 Test for specified micro-organisms | Sample preparation and pre-incubation steps are included to test cutaneous patches and medicated plasters against Pseudomonas aeruginosa and Staphylococcus aureus. | Laboratories should assess whether current absence-testing procedures align with the proposed patch/plaster approach. |
| 5.1.4 Microbiological quality of non-sterile pharmaceutical preparations | Acceptance criteria are added for cutaneous patches and medicated plasters. | Product specifications and release criteria may need to include TAMC, TYMC and absence requirements for the relevant specified organisms. |
| 2.8.13 Pesticide residues | A broader revision is proposed for pesticide limits, decision trees, ADI-based calculations, herbal drug preparations, analytical validation and multiple-source substances. | Herbal product manufacturers may need to re-check pesticide residue strategies, supplier data, GACP documentation, analytical method validation and risk assessments. |
| 2.9.27 Uniformity of delivered doses from multidose containers | “And accuracy” is deleted from the title. The chapter text itself remains unchanged. | Mainly a terminology and reference update, but SOPs, specifications, and regulatory documents should be checked for any instances where the old title is cited. |
Microbiological Quality: Cutaneous Patches and Medicated Plasters Are Brought Into Scope
The microbiology-related revisions should be read together. Ph. Eur. chapters 2.6.12, 2.6.13 and 5.1.4 are being updated as a connected package, with new provisions for cutaneous patches and medicated plasters.
This is not only a wording change. The proposed revisions define how these dosage forms should be prepared, how many units should be sampled, how membrane filtration should be performed, and which microbiological acceptance criteria apply.
Proposed Changes to 5.1.4 – Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use
Chapter 5.1.4 proposes new acceptance criteria for cutaneous patches and medicated plasters in Table 5.1.4.-1.
For cutaneous or transdermal patches, the limits apply to a single patch, including the adhesive layer and backing. For medicated plasters, the limits apply to one plaster, including the adhesive layer and backing.
The proposed criteria are:
| Dosage form | TAMC | TYMC | Specified micro-organisms |
|---|---|---|---|
| Cutaneous or transdermal patches | 10² CFU / patch | 10¹ CFU / patch | Absence of Staphylococcus aureus and Pseudomonas aeruginosa in 1 patch |
| Medicated plasters | 10² CFU / plaster | 10¹ CFU / plaster | Absence of Staphylococcus aureus and Pseudomonas aeruginosa in 1 plaster |
This means companies with these dosage forms should review finished-product specifications, microbiological release criteria, LIMS limits, CoA templates, and any outsourced testing agreements.
Proposed Changes to 2.6.12 – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
Chapter 2.6.12 is updated to describe how cutaneous patches and medicated plasters should be handled during microbial enumeration testing.
The existing preparation approach for transdermal patches is expanded to include cutaneous patches. A separate method is added for medicated plasters. In both cases, the release liner is removed, the adhesive side is placed upwards, the adhesive surface is covered with sterile porous material such as sterile gauze, and the unit is transferred into a suitable diluent containing inactivators such as polysorbate 80 and/or lecithin. The preparation is then shaken vigorously for at least 30 minutes.
The amount used for testing is also clarified: 10 cutaneous or transdermal patches and 10 medicated plasters are to be sampled, unless otherwise prescribed. For membrane filtration, 10% of the prepared sample volume is filtered separately through each of two sterile membranes, one for TAMC and one for TYMC.
Proposed Changes to 2.6.13 – Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms
Chapter 2.6.13 adds specific sample preparation and pre-incubation instructions for absence testing of Pseudomonas aeruginosa and Staphylococcus aureus in cutaneous patches and medicated plasters.
For these tests, the proposed text follows the same logic used for transdermal patches and orodispersible films: the volume of sample corresponding to 1 patch, 1 plaster or 1 film is filtered through a sterile membrane and placed in 100 mL of casein soya bean digest broth, followed by incubation at 30–35 °C for 18–24 hours.
For QC microbiology laboratories, the main point is method control. Adhesive layers, backing materials and inactivators can affect microbial recovery. If the draft is adopted, laboratories should be ready to show that the chosen preparation and filtration method is suitable for the product matrix.
Pesticide Residues: A Larger Revision for Herbal Drugs and Herbal Preparations
The proposed revision to 2.8.13, Pesticide residues, is the most substantial change in this group. The chapter has not been significantly revised for many years. EDQM states that the proposal reflects how agricultural and collection practices have evolved over roughly the last 18 years, together with recent batch data provided by manufacturers of herbal medicines.
The revision affects how limits are selected, how herbal drug preparations are treated, how analytical methods are validated, and how certain background substances are interpreted.
A Clearer Limit-Setting Process
The proposed chapter introduces two decision trees, one for herbal drugs and one for herbal drug preparations, to determine which pesticide residue limit applies. This matters because a limit for herbal material can come from several sources depending on the situation:
- a specific monograph limit;
- Table 2.8.13.-1;
- Regulation (EC) No 396/2005;
- an ADI-based calculation;
- a documented risk assessment where no limit is available or cannot be calculated.
The ADI formula itself is changed. The previously added 100-factor has been deleted because ADI values already include a safety factor. In practice, companies should not carry old spreadsheet formulas forward without checking them against the proposed text, since the calculated limits will differ.
The draft also broadens the ADI route: limits for pesticide residues can now be set using the ADI concept for any substance with an available ADI value, without first referring to Table 2.8.13-1 or Regulation (EC) No 396/2005.
The revision also draws a clearer line by intended use. For herbal drugs and herbal drug preparations intended for applications other than oral, the default position is now a risk assessment rather than a fixed numeric limit, unless the monograph states otherwise.
Table 2.8.13.-1 Has Been Rebuilt
The list of commonly detected pesticides and their maximum residue limits in Table 2.8.13.-1 has been reconstructed from recent batch data. The relevance of each pesticide was assessed by the number of available results and the share of positive results.
Limits are still proposed on a 90th-percentile basis, with a 0.01 ppm limit applied to very toxic and persistent pesticides for which no 90th-percentile value was available. Names and definitions have been aligned, wherever possible, with those used in European Union texts. This is arguably the single change most likely to move a specific limit for a specific substance, so a direct comparison of your current limits against the revised table is worthwhile.
Herbal Drug Preparations Are Addressed More Directly
The revision gives more attention to herbal drug preparations, not only to the herbal drug itself. For preparations intended for oral use, limits may be set using the ADI concept where an ADI value is available.
Where the processing factor concept is used, the draft distinguishes cases by the drug/extract ratio: if the DER is 10 or below, the processing factor expression applies, and if the DER is greater than 10, the ADI concept should be used or a risk assessment performed.
This matters for extracts, essential oils, expressed juices, herbal teas and powdered herbal products, because the pesticide result in the starting herbal drug does not always reflect the residue level in the final preparation.
New General Principles for Where to Test
A new general principles section clarifies that pesticides can be analyzed either in the herbal drug or in the herbal drug preparation, and confirms that the evaluation must always be completed before release of the herbal medicinal product. The draft also allows a herbal drug used for a preparation to exceed the applicable limit in certain cases, provided the finished preparation complies. That is a practical point for manufacturers working with extracts or concentrated preparations, where processing changes the residue profile.
Analytical Method Validation and Multiple-Source Substances
The analytical section is updated. The proposed chapter now refers to SANTE/11312/2021 v2026 in place of the older SANCO/10232/2006 document, and it introduces the matrix group concept for validating quantitative methods, so that validation is demonstrated on at least one representative matrix from each group analyzed.
A further addition is the treatment of multiple-source substances, also described as ubiquitous or dual-use substances. These have natural background levels that can exceed the limits normally applied to pesticides, which could otherwise place sound herbal drugs in an apparently non-compliant position.
A new Table 2.8.13.-2 sets acceptable background limits for frequently occurring substances, including bromide ion, chlorate, nicotine, anthraquinone, biphenyl, 2-phenylphenol and phthalimide, with a clear note that the list is not exhaustive.
For GMP purposes, this is not only an analytical update. It affects supplier qualification, raw material specifications, contract laboratory expectations, the interpretation of out-of-specification and out-of-trend results, and the quality agreement language used for herbal starting materials.
Related Article: Analytical Method Validation in Lab Testing
Delivered Dose Testing: Title Alignment for 2.9.27
The proposed revision to 2.9.27 is much narrower. The title would change from “Uniformity and accuracy of delivered doses from multidose containers” to “Uniformity of delivered doses from multidose containers.” EDQM explains that “and accuracy” is deleted for consistency with chapter 2.9.54 and with the dosage form monographs that describe uniformity of delivered dose testing. If accuracy is to be assessed, the requirement is stated in the individual monograph for the preparation.
The chapter text remains unchanged, so this is not a major operational change for laboratories. It does confirm a point of principle: accuracy of the delivered dose is a monograph-driven requirement, not a default carried by the general chapter title. Companies should still check SOP titles, specification references, validation protocols, regulatory dossiers and training materials where the old chapter title is cited.
What Companies Should Review Now
These drafts are still under consultation, but waiting until adoption often leads to avoidable remediation work.
For non-sterile patches and medicated plasters, companies should confirm whether current microbiological methods cover the full unit, including adhesive layer and backing, and whether sampling plans reflect the proposed number of units.
For herbal drugs and herbal drug preparations, the revision is broader. Companies should review pesticide residue specifications, ADI and DER calculations, supplier pesticide declarations, GACP information, contract laboratory methods and risk assessment procedures.
A practical gap assessment should cover:
- affected products and dosage forms;
- current specifications versus proposed Ph. Eur. criteria;
- laboratory sample preparation and method suitability data;
- pesticide residue calculation templates, including removal of the old 100-factor;
- the rebuilt Table 2.8.13.-1 and the new multiple-source substance limits;
- analytical method validation against the updated SANTE reference and matrix group concept;
- supplier and contract laboratory responsibilities;
- regulatory impact for approved products and pending submissions.
Final Takeaway
Pharmeuropa 38.3 does not yet introduce final requirements, but the proposed changes are sufficiently concrete to warrant early review. The microbiology revisions are targeted, and mainly affect cutaneous patches, transdermal patches, and medicated plasters, with the added point that these are Ph. Eur. local requirements. The revision of pesticide residues is broad and may affect the overall control strategy for herbal drugs and herbal drug preparations.
Companies with affected products should use the consultation period to compare the proposed text against current specifications, testing methods and supplier controls, and to submit comments before the 30 September 2026 deadline where product-specific concerns or technical constraints exist.
