Design Standards


Производството във фармацията и хранително-вкусовата промишленост трябва да отговаря на всякакви стандарти за чистота и безопасност на продукта. Поради това, тези индустрии са обект на постоянни, обстойни и задълбочени проверки от компетентни органи и всяко несъотвтествие с приетите международни стандарти може да доведе до тежки санкции и дори до спиране на производството. При козметичната и химическата промишленост, нещата също са обвързани с високи изисквания за безопасност и добри производствени практики.

При производството на нашите съоръжения, ние от „Интер Инженеринг-10” и от „ИНОКС” се съобразяваме с всички регулации и регулаторни органи за добри производствени практики, безопасност на продукта и процесите, както и с изискванията на производството на клиента.



Good Manufacturing Practice


Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. - Wikipedia


FDA Requirements


The Food and Drug Administration - FDA or USFDA is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.


The European Commission (EC)


The European Commission (EC) is the executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Commissioners swear an oath at the European Court of Justice in Luxembourg, pledging to respect the treaties and to be completely independent in carrying out their duties during their mandate.


Equipment for potentially explosive atmospheres (ATEX)


The ATEX 'Workplace' Directive 1999/92/EC deals with the minimum requirements for improving the level of health and safety protection of workers potentially at risk from explosive atmospheres. This Directive complements the responsibilities of manufacturers under 94/9/EC by setting out the responsibilities of employers. For its implementation, see the Non-binding Guide to good practice for implementing Directive 1999/92/EC. The Workplace Directive is under the responsibility of the Directorate-General for Employment, Social Affairs & Inclusion.


World Health Organization


World Health Organization is a specialized agency under the United Nations and it is responsible for international public health. The organization is frequently publishing reports which concern different pharmaceutical, food&drink and other industries with integrated Good Manufacturing Practices and hazardous or dangerous to the human health products.


SAMTS


STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE (SAMTS) is the state surveillance authority performing the national policy in the field of:

  • Market surveillance of products placed on the market and/or put into service under the scope of the New Approach Directives;
  • Market surveillance of construction products; products related to the energy consumption as regards the eco design requirements; electrical and electronic equipment in relation to the restrictions of the use of certain dangerous substances and its waste; 
  • Technical inspection of high-risk equipment;
  • Quality control of liquid fuels;
  • Metrological supervision;
  • Designation and supervision of conformity assessment bodies for products under the scope of the New Approach Directives.

Ministry of Health


Bulgarian Ministry of Health is a Bulgarian state institution which is responsible for the better health of the general public. The main means of doing so is by integrating prophylaxis, early diagnostics and effective treatment of people with diseases and disabilities.


Pharmacist Pharma Journal


Pharmacist Pharma Journal – A blogspot with useful pharmaceutical production practices and documentation


PICSCHEME


Pharmaceutical Inspection Co-operation Scheme – PICSCHEME - a website of useful information and documentation for the needs of the pharmaceutical industries




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