Manufacturing licence

A manufacturing licence is issued for each product, rather than to the manufacturer. Pharmacies do not need a formal licence, but must register with the Healthcare Inspectorate. Dispensing physicians must be licensed. 

Manufacturing Premises licence Manufacturing licence Product manufacturing licence 217-362 125... 

After the approval by the DCGI, the company would need to obtain the manufacturing licence from the concerned local state FDA office. The technical documents on the product as well as administrative/technical documents on the premises need to be furnished in this case. 

M/L Product Manufacturing Licence ML Product Import Licence... 

In the case of medicinal products originating from another country, the applicant shall submit an official document, along with a Portuguese translation, which proves the existence of the respective MA and manufacturing licence. 

A wholescile dealer s licence (Appendix 5) is issued to a person who is not the holder of the product or manufacturer licence, for the purpose of selling registered medicinal products to another company for rescile. The applicant must be a locally registered compgmy. 

Please list the pharmaceutical dosage forms you are licensed to manufacture by the national regulatory authority and attach a copy of the manufacturing licence(s) ... 

Look at the information provided on the manufacturing licence and product licence. Make notes of the aspects that need to be inspected to... 

Good Manufacturing Practices (GMP) for study drugs and the provision for a manufacturing licence for investigational medicinal products (IMPs), and labelling requirements... 

Manufacturers Licences were issued by the UK Licensing Authority from the inception of the Medicines Act to cover all manufacturing... 

Ideally, extemporaneous products are prepared from pure drugs (or less suitably from chemicals) but, more frequently, commercial dosage forms intended for adults are manipulated into a suitable form for administration to children. They should be prepared in registered premises (pharmacy, hospital, health centre) under the supervision of a pharmacist and in accordance with a prescription for administration to a particular patient or in anticipation of such a prescription. These manipulations come under the heading of magistral (extemporaneous) preparations. Specials have a similar status but are made in larger volumes by licensed manufacturers (licence issued by the MHRA in the UK), which include suitably licensed hospital units. However, these products are not always subjected to full quality assurance. 

Process validation would not be expected until commercial batches are produced but information on process boundaries and critical parameters should be obtained at this stage. It should also be pointed out that if the pivotal stability studies to be listed in the final registration (on the drug product or API) are performed on pilot batches, then this data certainly could become subject to inspection. It is becoming inaeasingly common in Europe and the USA for R D facilities to be audited as well as the commercial facility before approval of a manufacturing licence, even though the R D facility has not manufactured any commercial supplies. 

In the EU GMP Annex 1 aseptic preparation is used for the preparation of sterile products that cannot be sterilised in their final container [1]. In the UK the term aseptic preparation is used for aseptic handling without a manufacturing licence granted by the Competent Authority. 

The site master file describes both practical aspects, such as the address and the location of buildings, and quality aspects. For elaborate contents reference is made to the relevant PIC/S inspection guide [21]. The sequence of aspects is the same as in the GMP and also matches the form that a manufacturer should fill to obtain a manufacturing licence. 

A successful application to the regulatory authorities will result in the company obtaining, in the UK, a product licence, covering permission to sell the drug, and a manufacturing licence which is obtained by proving that the company has the facilities to make the drug reproducibly to the required quality. 

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