The contract must clearly state the way in which the authorised person releasing each batch of product for sale exercises his full responsibility

All arrangements for contract manufacture and analysis including any proposed changes in technical or other arrangements should have more priority than the marketing authorization

The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required

The Contract Giver does not need to ensure that the Contract Acceptor is fully aware of any problems associated with the product, if Acceptor following described matter in contract.

The Contract Giver should ensure that all processed products and materials delivered to him by the Contract Acceptor comply with their specifications or that the products have been released by an authorised person.

Contract manufacture can be undertaken only by a manufacturer who is approved by Contract Giver.

The Contract Acceptor should refrain from any activity which may adversely affect the quality of the product manufactured and/or analysed for the Contract Giver.

A contract should be drawn up by the Contract Giver only, which specifies their respective responsibilities relating to the manufacture and control of the product

The contract should specify the way in which the authorised person releasing the batch for sale ensures that each batch has been manufactured and checked for compliance with the requirements of Marketing Authorisation

The contract should describe clearly Contract Accepter is responsible for purchasing materials, testing and releasing materials, undertaking production and quality controls, including in process controls, and Contract Accepter has responsibility for sampling and analysis

Even in case of contract analysis, the Contract Giver should understand that he is subject to inspection by the competent Authorities

All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures

A person should be designated responsible for handling the complaints and deciding the measures to be taken together with sufficient supporting staff to assist him

Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for Quality Control should normally be involved in the study of such problems

All the decisions and measures taken as a result of a complaint should be recorded and referenced to the corresponding batch records

Special attention should be given to establishing whether a complaint was caused because of counterfeiting

Recall operations should be done after organize project team promptly

Self-inspections should be conducted in order to monitor the implementation and compliance  with  Good  Manufacturing  Practice  principles  and  to  propose  necessary corrective measures

Self-inspections  should  be  conducted  in  an  independent  and  detailed  way  by designated competent person(s) from the company. Independent audits by external experts must not be used.

All self-inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded

When  submitted  to  a  regulatory  authority,  the  Site  Master  File  should  provide information as detailed as possible in order that inspector(s) can fully understand the manufacturer’s GMP related activities.

The Site Master File (SMF) should have an edition number. Each Appendix of SMF can have an individual effective date, independent from revision of the main text of SMF.

The Site Master File should include information about size and layout of the site, e.g. simple plans of manufacturing areas with indication of scale, but detailed engineering drawings are not required

Product list in Site Master File should include sales name and strength of each product

Regarding to product distribution, Site Master File should include information on measures to maintain product traceability and to prevent the products to fall in the illegal supply chain.