Process regulations are divided into the following categories:
A laboratory regulation is a process document, which finalizes researches in a laboratory environment when developing a production method (of chemical compounds, medicines, etc.).
- laboratory regulations (LR);
- pilot industrial regulations (PIR);
- start-up (time) regulations (SUR);
- industrial regulations (IR).
A laboratory regulation is a process document, which finalizes researches in a laboratory environment when developing a production method (of chemical compounds, medicines, etc.).
The laboratory regulation is used:
A pilot industrial regulation (PIR) is a process document that finalizes fine-tuning of a new production technology (for chemical compounds, medicines, etc.) using a pilot plant.
- when designing and operating a pilot plant;
- when fine-tuning a new production technology;
- when producing a new substance for clinical tests;
- drug samples in order to study their stability and to develop draft temporary pharmacopoeial monographs (TPM) or draft technical specifications..
A pilot industrial regulation (PIR) is a process document that finalizes fine-tuning of a new production technology (for chemical compounds, medicines, etc.) using a pilot plant.
The PIR is used:
The start-up (time) regulation (SUR) is a process document used as a basis for commissioning and mastering of newly developed industrial production (of chemical compounds, medicines, etc.).
A process regulation is a document for existing serial production (of chemical compounds, medicines, etc.). The process regulation is compiled on the basis of the start-up regulation, after changes and additions made thereto during mastering of a production facility.
- for manufacturing and testing of pilot lots of new products;
- in pilot conditions;
- for fine-tuning of qualitative indicators of new products introduced in regulatory documentation (manufacturer’s monograph, specification);
- when compiling the data for designing of new industrial products.
The start-up (time) regulation (SUR) is a process document used as a basis for commissioning and mastering of newly developed industrial production (of chemical compounds, medicines, etc.).
The start-up regulation is compiled based on the pilot industrial regulation and design documentation for these
products, as well as based on existing production facilities, which technology is fundamentally changed. Validity period
A process regulation is a document for existing serial production (of chemical compounds, medicines, etc.). The process regulation is compiled on the basis of the start-up regulation, after changes and additions made thereto during mastering of a production facility.
The prerogative of a production process regulation development is reserved for the company itself.
Legislation allows for outsourcing.
If the process regulation is developed by an outsourced party, then it must be approved by a customer. All outsourced parties must be licensed by Rostekhnadzor for such works.
The industrial process regulation is approved by the company head. The process regulation establishes the sequence of operations, such as:
The process regulation in pharmaceutical and chemical industries is among the mandatory documents. A company may not continue production without it or if its validity period is over.
- best possible process mode;
- contains a description of materials, raw materials, semi-finished products, reagents;
- procedure of process operations and their control, flow diagram;
- standards of consumables and technology modes;
- ensures the products are of required quality;
- regulates safe operating conditions;
- contains description of sewage, waste, emissions into the air and methods of how to dispose and recycle them;
- a list of mandatory process instructions and regulatory documents, in accordance with which finished products are released by a company;
- determines how to observe environmental protection requirements.
The process regulation in pharmaceutical and chemical industries is among the mandatory documents. A company may not continue production without it or if its validity period is over.
The company's head is entitled to cancel the process regulation, if it does not provide for certain legal (mandatory) requirements, including as follows:
- does not allow to release finished products with the required quality;
- does not allow to achieve the required level of occupational safety;
- does not ensure compliance with established environmental protection requirements and in other cases.
The developed process regulation may require compulsory registration with supervisory bodies, for example, in case of a fire and explosive process or of a process with another hazard category (associated with chemical hazard), all process documentation is to be approved by the local or central Rostekhnadzor office.
