Z Luoyang Zhengmu Bio-Tech Veterinary API Manufacturer · China Request a Quote
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GMP Certification & Quality Documentation

Veterinary drug GMP certification, batch release against four pharmacopoeias, and the paperwork your registration file needs.
Luoyang Zhengmu Bio-Tech Co., Ltd. has successfully certified to the GMP of veterinary drug. That certificate is the legal basis for manufacturing the sulfa and quinolone APIs listed on this site, and it is what a customer's quality department is really buying when they place an order.

What the GMP certificate covers

GMP certification for veterinary medicines covers the manufacture of veterinary APIs at the Yanshi site: synthesis, refinement, drying, packing and the quality control that releases each batch. It is issued for the products and processes declared in the certification file, so the scope of the certificate is worth reading before you assume a new product is covered.

Certification

Veterinary drug GMP certificate for API manufacture at the Yanshi plant in Henan Province.

Release standard

Batch release against ChP, BP, EP or USP, chosen to match your registration dossier.

Traceability

Batch number, manufacture and expiry date recorded from raw material receipt to packed drum.

Documentation package

The following documents are available for supplier qualification. Where a document is product specific, it is issued per batch or per product rather than as a generic file.
DocumentWhen it is issued
GMP certificateOn request during supplier qualification
Certificate of analysisWith every batch, product specific
Material safety data sheetWith every product, updated on revision
Specification sheetBefore quotation, on request
Manufacturing flow chartFor registration support, under confidentiality
Stability data summaryFor registration support, per product
Batch record extractDuring customer audit

How quality is controlled in production

Quality management follows written operating procedures. Raw materials are qualified before use, in-process controls are run at defined points, and finished product is tested in the on-site laboratory before release. Where a result falls outside specification, the batch is held and investigated rather than shipped with a note.
The analytical toolkit is on site: HPLC and GC for assay and impurities, infrared and ultraviolet spectrophotometry for identity, titration, moisture determination, melting point, pH and particle counting. Cleanliness of the finishing plant is monitored with a dust particle counter.

For registration holders

If you are filing or maintaining a registration that depends on a Zhengmu API, speak to us before you file rather than after. The specification you write into the dossier has to match what we can routinely release, and the impurity profile has to match the route we actually run. Getting that alignment early avoids a variation later.

Need the certificate and a sample COA?

Tell us the product and the market you are registering in. We will send the documents that apply to it.
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Adhering to the principle of "quality first, customer first" and taking "scientific and technological innovation, casting first-class brand" as the direction of development, we sincerely hope to have cooperation with customers in various forms got achieving common development and creating brilliant future!