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Back NEWS REPUBLIC of INDONESIA No. 397, 2012 RULES the HEAD of FOOD and DRUG WATCHDOG AGENCY of the REPUBLIC of INDONESIA NUMBER HK. 04.1.33.12.11.09937 in 2011 ABOUT the PROCEDURES for CERTIFICATION of MAKING GOOD MEDICINE with the GRACE of GOD ALMIGHTY HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, Considering: that in order to implement the provisions of article 8 paragraph (4) of the regulation of the Minister of health Number 1799/Menkes/Per/XII/2010 2010 about the pharmaceutical industry needs to set the rules of the Chief food and drug Watchdog Agency about the procedures for Certification How to Manufacture a drug that either;
Remember: 1. Hard Drugs Ordinance (Staatsblad Number 419, 1949);
2. Act No. 5 of 1997 on psychotropic substances (Gazette of the Republic of Indonesia number 10 in 1997, an additional Sheet of the Republic of Indonesia Number 3671);
3. Act No. 35 of 2009 about Illegals (Gazette of the Republic of Indonesia Number 143 in 2009, an additional Sheet of the Republic of Indonesia Number 5062);
4. Act No. 36 of 2009 about health (State Gazette of the Republic of Indonesia Number 144 in 2009, an additional Sheet of the Republic of Indonesia Number 5063);
5. Government Regulation Number 72 in 1998 about Security Preparations pharmaceutical and health equipment (State Gazette of the Republic of Indonesia Number 138 in 1998, an additional Sheet of the Republic of Indonesia Number 3781);
6. Government Regulation Number 51 of 2009 about Kefarmasian Jobs (Gazette of the Republic of Indonesia Number 124 in 2009, an additional Sheet of the Republic of Indonesia Number 5023);
7. Presidential Decree Number 103 in 2001 about the position, duties, functions, authorities, Organization of work and the Non Governmental Departments as it has several times changed the last presidential regulation Number 64 in 2005;
8. Presidential Decree Number 110 in 2001 about the Task and Organizational Unit Echelons of Non Government agencies I Department as it has several times changed the last presidential regulation Number 52 in 2005;
9. Regulation of the Minister of health the number 1248/Menkes/Per/XII/2009 in 2009 about the Organization of the Ministry of the Cyclotron in the hospital;
10. Regulation of the Minister of health Number 1799/Menkes/Per/XII/2010 2010 about the pharmaceutical industry;
11. The decision of the head of the food and drug Supervisory Agency Number 02001/SK/KBPOM 2001 about the Organization and the Work of drug and food Supervisory Agency as amended by decision of the head of the food and drug Supervisory Agency Number HK. 00.05.21.4231 2004;
12. The decision of the head of the food and drug Supervisory Agency Number 05018/SK/KBPOM 2001 about the Organization and the work of Implementing Technical Environment Food and drug Watchdog Agency as it has several times the last modified by regulation the head of food and drug Watchdog Agency Number HK. 00.05.21.3546 in 2009;
13. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.3.0027 2006 Penerapanan Guidelines about the way of making a good remedy in 2006 as amended by the decision of the head of the food and drug Supervisory Agency Number HK. 03.1.23.09.10.9030 in 2010;
DECIDED: setting: RULE the HEAD of FOOD and DRUG WATCHDOG AGENCY ABOUT the PROCEDURES for CERTIFICATION PREPARATION a GOOD REMEDY.
CHAPTER I GENERAL PROVISIONS article 1 in this rule is: 1. Drugs is material or alloy materials, including biological products used to influence or investigating system Physiology or pathology in order to state the determination of diagnosis, prevention, healing, recovery, improving health and contraception for humans.
2. the Medicinal Ingredient is a material good nutritious nutritious or not used in drug processing and quality standard as pharmaceutical raw materials.
3. The active Medicinal Ingredient is any material or mixture of materials used in the manufacture of the drug substance as an active drug that is aimed at creating a pharmacological efficacy or other direct effect in the diagnosis, cure, peredaan, treatment or prevention of disease or to affect the structure and function of the body.
4. The pharmaceutical industry is a business entity that has a permit from the Minister of health to conduct the activities of making drugs or drug ingredients.
5. Making a good remedy, hereinafter abbreviated to CPOB is a way of making drugs that aim to ensure the quality of drugs produced in accordance with the terms and purposes of use.
6. Form of the drug is the identification of the Dosage form related to the physical appearance of a physical or a way of granting a remedy.
7. How to Manufacture the active ingredient in a drug that Both hereinafter abbreviated as CPBBAOB, is a way of making the process of creating and controlling the active ingredients of the drug to achieve a consistent standard of quality according to the purpose of use and the requirements and specifications of the material.
8. Audit of Eligibility CPOB hereinafter called the inspection is the examination directly against the pharmaceutical industry to know the fulfillment of the terms CPOB and/or CPBBAOB.
9. CPOB Certificate is a document which is valid proof that the pharmaceutical industry has met the requirements of CPOB in making one type of drug dosage forms.
10. CPBBAOB Certificate is a document which is valid proof that the pharmaceutical industry has met the requirements of CPBBAOB in producing one type of active ingredient in the drug.
11. The Director is the Director of production monitoring Therapeutic Products supply and Household Health.
12. The head of the food and drug Supervisory Agency, hereinafter called the head of the Agency is the head of the Agency's tasks and responsibilities in the field of supervision of food and drug.
CHAPTER II CERTIFICATE article 2 (1) the pharmaceutical industry which makes mandatory Drug meets the requirements in the guidelines CPOB.
(2) in addition to the provisions referred to in subsection (1), the pharmaceutical industry makes the raw materials Active mandatory Drug meets the requirements in the guidelines CPBBAOB.
Article 3 in addition to the pharmaceutical industry as referred to in article 2: a. institutions that perform the process of making preparations radiofarmaka and has received consideration from an authorized institution in the field of supervision of nuclear power; and b. the installation pharmacy hospitals that do the manufacturing process of the drug for the purposes of the implementation of health services at the hospital are concerned; obliged to meet the requirements of CPOB.
Article 4 eligibility CPOB and/or CPBBAOB as referred to in article 2 and article 3 is evidenced by a certificate.
Article 5 (1) a certificate of CPOB given for each unit of the building in accordance with the form of the material and the manufacturing process is done for all stages or partial phases.
(2) a certificate of CPBBAOB given for each unit building with this type of Active ingredient in a drug that is made.
(3) a certificate issued in accordance with CPOB examples in form 1 as attached.
(4) a certificate issued in accordance with CPBBAOB examples in Form 2, as attached.
(5) a list of the types of Certificates CPOB and CPBBAOB are listed in the annex which is part an integral part of this regulation.
(6) the list of types of CPOB Certificates as referred to in subsection (5) may be modified in accordance with the development of science and technology.
Article 6 on the basis of studies and inspections, the head of the Agency may publish the certificate CPBBAOB for the industry that makes the material not used in the processing of efficacious drugs with a quality standard in accordance with the Pharmacopoeia ORDINANCE CHAPTER III OBTAIN CERTIFICATES One Common Part of article 7 (1) Certificate CPOB/CPBBAOB published on the basis of a written application to the head of the Agency.
(2) a written Application referred to in subsection (1) is filed using Form example 3 as enclosed.
Article 8 (1) of the certification application CPOB charged in accordance with government regulations regarding the type and price of the Above types of acceptance of a country not a tax (PNBP) applicable to the food and drug Supervisory Agency.
(2) the fee referred to in subsection (1) who have paid can not be pulled back.
The second part of the new Certificates article 9 (1) in the framework of the new Certification, the applicant delivered a petition for approval of the master plan of development (RIP) to Head the Agency.
(2) within a period of fourteen (14) working days since the receipt of the application for the evaluation of conformity do RIP-OFF with the requirements CPOB.
(3) based on the results of the evaluation as referred to in paragraph (2), the head of the Agency issuing the approval: a. RIP, if declared ineligible; or b. the repair request letter RIP, when stated have not been qualified.
(4) the head of the Agency bestows the authority granting the approval of RIP to the Director.
(5) the applicant reported on the progress of development periodically every 3 (three) months to the Director by using the example of the form 4 as attached.
Article 11 (1) after construction is complete and the done qualifying, applicants applying for Certification by using the attached Form 5 as an example.
(2) the longest within 20 (twenty) working days since the receipt of the application referred to in subsection (1) the head of the agency conducting the inspection.
(3) based on the results of the Inspections referred to in paragraph (2) the head of the Agency conveyed the eligibility evaluation CPOB to the applicant.
The fourth part Publication Certificate article 12 (1) the longest within 10 (ten) working days since the declared eligible CPOB based on the evaluation of the results of the inspections referred to in article 11 paragraph (2), the head of the Agency's published: a. recommendations eligibility CPOB as completeness in order to permit the application for the pharmaceutical industry; or b. the certificate CPOB.
(2) specifically in order to permit the application for the pharmaceutical industry as referred to in paragraph (1) letter a, CPOB Certificates will be published after the pharmaceutical industry pharmaceutical industry obtain permission.
Article 13 the certificate is valid for 5 (five) year during which concerned still produce and meet the requirements in accordance with the legislation.
Part five Certificate Change articles 14 (1) the holder of a certificate of the legal entity name changes and address must apply the change certificate.
(2) the validity period of the certificate referred to in subsection (1) following the expiration of the previous certificate.
The sixth Resertifikasi part of article 15 (1) the holder of a certificate is compulsory to apply resertifikasi within 6 (six) months prior to the expiration of the certificate expires.
(2) the petition presented to the head of resertifikasi Agency uses examples Form 6 as attached.
(3) Resertifikasi is done through assessment of the fulfillment of the CPOB/CPBBAOB based on the results of routine inspections, product release history, and/or inspection in order to resertifikasi when needed.
(4) violation of the obligation of doing administrative sanctions are resertifikasi in the form of temporary suspension of activities.
CHAPTER IV CHANGE MEANS in FACILITIES that HAVE BEEN CERTIFIED article 16 (1) the holder of the certificate that will be meaningful change against CPOB eligibility, either to change the capacity and/or mandatory production facilities applying for approval to Head the Agency. (2) changes means as referred to in subsection (1) include the following: a. changes in production capacity because of a change, a change of equipment; b. the system change the grammar of air and/or water treatment systems;
c. the equipment changes have a direct impact on the sterility of the product;
d. change the vendor product creation process for biological biology; or e. the addition of warehouse.
(3) the changes referred to in paragraph (2) that require approval by first performed the inspections include the following: a. addition of a room change related production capacity;
b. changes in the system of governance of the air space of production;
c. change of vendor product creation process for biological biology; and/or d. addition of warehouses outside the address listed on the permission of the pharmaceutical industry.
(4) the changes referred to in paragraph (2) which should be dinotifikasi by passing related documents include: a. changes in equipment that have a direct impact on the sterility of the product;
b. addition of production capacity with the change of the function of the room cleanliness and class without change or alteration of the equipment; c. change of meaning on the water treatment systems; and/or d. addition of sheds in one location the pharmaceutical industry.
(5) the head of the Agency gives approval of changes by using the attached form 7 as an example.
(6) a violation of the provisions referred to in subsection (1), subsection (2), subsection (3) or subsection (4) are the administrative sanction in the form of: a. a warning;
b. strong warning;
c. suspension of activities;
d. Certificate freezing CPOB/CPBBAOB;
e. Revocation Certificate CPOB/CPBBAOB; and/or f. revocation recommendation of the pharmaceutical industry;
Chapter V TRANSITIONAL PROVISIONS article 17 (1) a certificate that has the Fasillitas CPOB without validity period must comply with the requirements and applying for resertifikasi at least 12 (twelve) months from the date of promulgation of these regulations.
(2) a certificate of CPOB has been published prior to the entry into force of this regulation remains valid until expiration indicated on the certificate.
CHAPTER VI CLOSING PROVISIONS Article 18 this Regulation comes into force on the date of promulgation.
In order to make everyone aware of it, ordered the enactment of this regulation with its placement in the news of the Republic of Indonesia.
Established in Jakarta on December 2, 2011 HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, KUSTANTINAH Enacted in Jakarta on 9 April 2012 the MINISTER of LAW and HUMAN RIGHTS REPUBLIC of INDONESIA, AMIR SYAMSUDDIN lamp fnFooter ();
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