Manufacturing authorisation

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

Proof of payment, rights of reference letters, flow charts of production sites, manufacturing authorisations, CMP certificates, etc.)... 

References Reference number of Marketing and / or Manufacturing Authorisations EMEA reference number(s).(lf the inspection is an EMEA inspection). 

Letter of authorization from the manufacturer authorising the local agent to be the registration holder. 

Under the terms of Article 54 of this instrument, prior manufacturing authorisation is required for generators, inactive kits, precursors and all other industrially prepared radioactive drugs. 

Manufacturers must ensure that production occurs in accordance with GMP, and with the manufacturing authorisation. Imports from non-EU countries must have been produced to standards at least equivalent to those in the EU, and the importer must ensure this. 

Full testing or qualitative and quantitative requirements mentioned in the specifications for starting materials is not normally performed on intermediate fractions of blood products. Control reports issued by the producer of the intermediate material, including plasma, will suffice, provided that the producer is a manufacturer authorised in accordance with national legislation, is regularly inspected and there is a history of reliability and consistency. 

The persons responsible for these duties must meet the qualification requirements laid down in Article 23 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the manufacturing authorisation to carry out their responsibilities. Their responsibilities may be delegated, but only to other QP(s). 

Each holder of a manufacturing authorisation should have a... 

NOTE This Chapter deals with the responsibilities of manufacturers towards the competent authorities of the Member States with respect to the granting of marketing and manufacturing authorisations. It is not intended in any way to affect the respective liability of Contract Acceptors and Contract Givers to consumers this is governed by other provisions of Community and national law. 

The Contract Acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the Contract Giver. Contract manufacture may be undertaken only by a manufacturer who is the holder of a manufacturing authorisation. 

The holder of a manufacturing authorisation must manufacture pharmaceutical products so as to ensure that they are fit for their... 

Each holder of a manufacturing authorisation should have a Quality Control Department This department should be independent from other departments, and under the authority of a person with appropriate qualifications and experience, who has one or several control laboratories at his disposal. Adequate resources must be available to ensure that all the quality control arrangements are effectively and reliably carried out. 

Treatment by irradiation may be carried out by the pharmaceutical manufacturer or by an operator of a radiation facility under contract (a contract manufacturer ), both of whom must hold an appropriate manufacturing authorisation. 

EU GMP guidelines are located in Volume 4 of the Rules [16]. This Volume is also called the current GMP (c-GMP). Compliance with c-GMP is a prerequisite for a manufacturing authorisation. Compliance is assessed by the Competent Authority. 

---