Internal Regulations

Internal Regulations of the Employers' Union of Pharmaceutical Industry Machine Makers of Iran

Article 1 - Objectives, application and definitions

1. Objectives: This regulation has been compiled with the following objectives:

• Development of pharmaceutical machinery industry in the country
• Facilitating and making it possible to export domestic products in this field
• Competitiveness of domestic products compared to foreign products
• Communication with chambers and related organizations and bodies
• Analyzing the industry and reflecting relevant statistics and information to government and decision-making authorities
• Helping to formulate rules and regulations in government departments
• Improving internal knowledge in the field of pharmaceutical machinery by activating the discussion of education and research

2. Application: This regulation is used as a document agreed upon by all members of the Iranian Pharmaceutical Industry Machine Builders Association to carry out all the current and executive affairs of this association.
3. Definitions: Pharmaceutical machinery means the construction and production of machines that are used directly in the production lines of pharmaceutical factories.

Article 2- Members of the association

• Types of membership in the forum:

The association will have three types of members according to their position in the association : main member, associate member and honorary member
2-1-1 . All companies And Institutions employed At Activities mentioned in The association's statutes and article 2-2 of this regulation That qualified Conditions Necessary according to Rules included At Ritual Letter Internal association be; may can At this association Member become And they will be referred to as "principal members" and their official representatives have the right to vote in assemblies .
 2-1-2 Legal entities that do not have the mentioned characteristics for main membership, but are recognized as effective in achieving the goals of the association, according to the opinion of the board of directors, can be elected as associate members. After being a member of the association for some time, the associate member will become the main member according to the conditions determined by the board of directors .
 2-1-3 An honorary member is selected by the board of directors from among individuals, public and private officials, Iranian and foreign scientists who have distinguished scientific studies and research, or who have provided valuable services to the advancement of the country's industry or the achievement of the association's goals .
 The main members are selected with the approval of the board of directors or a committee chosen by the board of directors. The main members have the right to vote in the assemblies to be members Dependent And honorary With approved Board Fashion , choice they turn

• Member Rating:

• History of activity as a machinist in the pharmaceutical industry , 2 points up to a maximum of 20 points per year
• The amount of technology used in products according to the judgment of the technical committee up to a maximum of 20 points
• H age of fame According to the opinion of the board of directors, up to 5 points
• The number of insured people up to 10 people 5 points - between 10 and 25 people 10 points and more than 25 people 15 points
• Knowledge base license and business license : knowledge base 10 points, Ministry of Security license 5 points
• Having ISO standards and CE up to a maximum of 15 points as determined by the technical committee
• 's documents and documents such as DQ , IQ, OQ according to the diagnosis of the technical quantity up to a maximum of 10

According to the above provisions, the members of the association will be divided into three groups: distinguished (5 stars), total points 75 and above, professional (3 stars), total points 50 and above and normal, total points less than 50.

• Division of members based on the type of activity:

This division is based on the activities and productions of the member companies, and the members of the Pharmaceutical Machine Manufacturers Association of Iran according to the type machinery production, must be the producer of one or a number of the following categories :

• Solids production line machinery _ _ _ In the pharmacist
• Machines of production lines of materials _ _ _ In the pharmacist
• Machines of solid fog production lines _ _ _ _ In the pharmacist

Note 1: Membership in the association will be done according to the decision of the board of directors and based on cases and documents.

Note 2 : Determining the criteria for membership and eligibility of members is one of the powers of the general assembly , these criteria are prepared and compiled by the board of directors and after approval It will be valid in the general meeting . In the event that due to the ineligibility of any of the applicants , their membership request is not accepted by the board of directors , the applicant can appeal to the inspector . The law of declaration d . The decision of the assembly in this case will be final and binding . The board of directors will be obliged to raise the issue in the agenda of the first meeting of the general assembly after the objection of the applicant .

note 3 : If any of the suspended members lose their membership conditions in the association , while being required to fulfill the previous obligations , they will be recognized as resigned from the membership in the association .

Article 3- Association committees

• The association's committees include the following:

3-1-1 Technical Committee, Education and Research

3-1-2 Legal Committee

3-2 Duties of committees:

3-2-1 Technical, Education and Research Committee:

The task of examining license inquiries for import requests for pharmaceutical devices and machinery and approving or rejecting said inquiries that are sent by legal authorities, as well as all technical issues related to the association, reviewing the laws and standards of the world and Executive instructions based on the studies and researches carried out and also promoting the discussion of education by holding classes and courses The training approved by the association for the employees of the member companies is one of the most important duties of this committee.

3-2-2 Legal Committee:

One of the most important duties of this committee will be handling the complaints and legal issues of the members of the association in cases that occur between the members or outside the members of the association. If needed, this committee can hire a legal consultant to deal with the mentioned cases.

Note 4: In their first meetings, the committees compile their internal regulations and submit them to the board of directors of the association so that they can be implemented as the regulations of the committees if approved by the board of directors of the association.

Article 4 - Machine production requirements Pharmaceutical devices and equipment

4-1 Compliance with GMP GMP :

Obtaining GMP is one of the basic principles and requirements of the pharmaceutical industry. Obtaining this standard requires the existence of building bases , equipment , personnel and working documents so that the organization can obtain GMP . All members of the association are committed to carry out production activities based on the mentioned principles.

4-1-1 GMP Definitions: In Appendix 1 of this regulation, all relevant definitions are given.

2-4 Compliance with government laws and regulations:

Compliance with the approved instructions and laws notified by the government in the relevant production areas, which are issued by ministries such as the Ministry of Privacy , the Ministry of Health, Medical Education , etc.; It is one of the duties of the members of the association.

Informing, announcing and publishing these rules by the association for the information of all members should be done through possible and usual ways such as the association's website and social groups or by sending letters.

Article 5 – Show the quality of production _ _ _ _

With the aim of establishing the necessary standards for the production of machinery for the pharmaceutical industry, the association deems it necessary to implement the following processes in order to receive the quality approval mark of the association for the devices and machines produced by the members, in case of their request to receive this mark.

5-1 The following provisions are among the requirements to receive the association's quality approval mark for members' productions:

• edit Guides And Instructions I see To special To describe the operation of the device and Use From Tool And And Sayal And facilities , to as Clear , operational , with Tongue simple And Without Ambiguity
• keeping documents And Records levels Different produce From Sentence Records Full And able tracking Distribution To the face Comprehensive And able available Distribution the product I see With At least updated every Kind problems At Quality they _
• Existence one system Check And handling To complaint Hi has arrived At item the product Hi production sold Checked _ _ the reason defects Quality , performance Actions corrective And prevention From repeat they
• Compilation and existence of the device specification form including capacity and energy supply
• Proof of letters and related documents including manuals and catalogs
• Providing design and production quality assurance documents _

5-2 How to get the association's quality approval badge

• Written request from the manufacturer of the device
• Checking the application in the administrative system of the association
• Referring the request to the technical supervisor of the forum
• Receiving and checking documents and documents by the inspectors of the association
• Visiting the relevant production line
• Checking the necessary standards regarding the raw materials used
• Written report of technical inspectors to the board of directors
• , the board of directors of the association will vote and announce its opinion regarding the issuance or non-issuance of the product quality approval certificate for the requested item .
• the board of directors, the applicant will be awarded the quality certification badge, and the status will be announced in a letter to the vice president of machinery manufacturing of the Ministry of Safety, and the relevant information will be posted on the association's website.
• Declaration of satisfaction from three previous customers who bought the product of the mentioned company.
• At least manufacturing 3 cars with at least 3 years of installing the device in the car buyer's company.

Article 7 - Support

Based on its duties, the association supports all its members for the import of similar domestically produced products, provided that it has obtained the desired and approved standards of the association.

In this regard, upon the request of the members, the Technical Licensing Committee should review the issue and evaluate the ability of the requesting member to produce, while issuing its decision, it will inform the Ministry of Security.

Article 8 - Crimes

In case of a violation of the provisions of this regulation or a complaint by the buyer, the member company of the association will be given a deadline to resolve the issues and problems or obtain satisfaction within 1 working week; Otherwise, the board of directors of the association can suspend or cancel the membership of the relevant member.

Article 9 –

This regulation was approved and approved in 9 articles, 4 notes and 1 appendix on May 6, 1401.

Appendix 1:

• Qualifications _ _ _ _ _ _ Validation of pharmaceutical equipment and processes _ _ _ _ _ _ _ ( JMP _ _ _ GMP stands for good manufacturing conditions d Good Manufacturing Practice , in fact , is a part of the quality principles that are applied in quality assurance ; _ _ _ _ _ _ so that it does not guarantee that the product will be continuously controlled according to the quality standards .
• PIC / S protection is a pharmaceutical industry inspection and editing convention that mainly developed and European countries have joined , it includes protocols that its member countries _ _ _ _ _ They apply standards and requirements in the field of GMP and pharmaceutical industry inspection . _ PIC / S member countries and organizations must comply with the criteria and requirements to inspect and monitor the quality of drug production . _ _ ( Islamic Republic of Iran is the 50th member of this convention _ _ _ _ Is. )
• Validation Master Plan or VMP _ It is a document that explains when and how a validation plan should be implemented in a factory ( facility ) . _ _ _
• The validity of IQ installation includes checking There are a number of documents that are the reason for the evaluation of the structure and assembled parts of the device, which should be evaluated based on the approved characteristics of the device according to applicable codes and the manufacturer 's specifications. And engineering principles are not very important in this system . _ _ _ _ _ _
• The validity of OQ operations is also predicted based on experiments and tests aimed at measuring the unit 's performance and the system . _ _ _ _ _ _ The device controls operational indicators based on system communication requirements . _ _ _ _ _ _ _
• Performance suitability _ _ _ PQ performance is followed based on ensuring performance within acceptable limits . The critical and revalidation systems themselves include a special execution situation that affects the production performance . _ _ _ _ _ _ _ The quality of the products has a certain effect . _ _

Note 5: The World Health Organization (WHO) has established a set of rules and principles of GMP , which consists of 17 principles. GMP Principles of the Internal Audit Convention ( PIC / S )  which is written as GMP - PIC/ S It has 9 principles .

Note 6: To as Summary the part Hi From One the unit or a pharmaceutical manufacturing plant That under Rules GMP appointment may They include 14 topics that are from :

• Production sale
• Building
• Equipment And device I see
• Personnel
• cleaning
• experiments Materials primitive
• Control Production
• the part Control Qualitative
• experiments Materials Closed classification
• experiments the product final
• Documentation
• Sample I see
• handling To Complaints
• call the product

And among these cases, item 3, that is, equipment and devices, is emphasized and commented on by this association.

Note 7 : The VMP validation branch is divided into the following branches : validation of equipment , validation of facilities , validation of the HVAC system , validation of the cleaning process , _ _ _ _ _ _ _ _ _ _ _ _ Validation of the process , validation of analysis methods and validation of the computer system . _ _ _ _ _ _ _ They are used in the same way _ _ _ Accreditation of systems and equipment _ _ _ which is effective for the members of this forum; It is divided into the following branches : _ _ _

• Validation of DQ designer _ _ _ Design qualification
• Validation of CQ components _ _ Component qualification
• IQ installation validation _ _ _ Installation qualification
• Validation of OQ operations _ _ _ _ _ Operational qualification
• Validation of PQ efficiency _ _ _ Performance qualification

Note 8: GMP-WHO principles consist of 17 principles , which are as follows :

• Quality Assurance
• GMP
• Factory Sanitation & Hygiene
• Qualification & Validation
• Complaints
• Product Recalls
• Contract Production & Analysis
• Self-Inspection & Quality Audits
• Personnel
• Training
• Personal Hygiene
• Premises
• Equipment
• Materials
• Documentation
• Good Practices In Production
• Good Practices In Quality Control