Peraturan Presiden Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan (Berita Negara Republik Indonesia Tahun 2017 Nomor 180); Pada saat Peraturan Badan ini mulai berlaku, Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK Tahun 2012 tentang Penerapan Pedoman Cara Pembuatan Obat yang Baik (Berita Negara Republik Indonesia Tahun 2012, 122), sebagaimana telah diubah dengan Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2018 tentang Perubahan Atas Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK Tahun 2012 tentang Penerapan Pedoman Cara Pembuatan Obat Yang Baik Untuk obat (Berita Negara Republik Indonesia Tahun 2012 Nomor 985) dicabut dan dinyatakan tidak berlaku.
MANUFACTURE OF RADIOPHARMA-
ANEKS 10 – PENGGUNAAN RADIASI PENGION DALAM
SAMPEL PEMBANDING DAN SAMPEL
USE OF IONISING RADIATION IN THE MANUFACTURE OF
PELULUSAN REAL TIME DAN PELULUSAN
MANAJEMEN RISIKO MUTU
REAL TIME RELEASE TESTING AND
QUALITY RISK
HK 2012 tentang Penerapan Pedoman Cara Pembuatan Obat yang Baik Tahun 2012 sebagaimana telah diubah dengan Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2018 yang mengacu pada Guidance PIC/s GMP doc. Cara Pembuatan Obat yang Baik (CPOB) bertujuan untuk memastikan bahwa obat diproduksi secara konsisten, memenuhi persyaratan yang ditentukan, dan konsisten dengan tujuan penggunaannya.
PENDAHULUAN INTRODUCTION
Pedoman Cara Pembuatan yang Baik atau diganti dengan pedoman alternatif untuk mencapai tingkat jaminan mutu minimum yang setara. Konsep dasar manajemen mutu, praktek pembuatan farmasi yang baik (CPOB) dan manajemen risiko mutu saling berkaitan.
PHARMACEUTICAL QUALITY SYSTEM
Untuk mencapai sasaran mutu yang dapat diandalkan memerlukan sistem mutu untuk industri farmasi yang dirancang secara komprehensif dan diterapkan dengan benar serta mencakup metode pembuatan obat yang baik dan manajemen risiko mutu. Tanggung jawab hukum tambahan terletak pada pemegang lisensi industri farmasi (IIF) dan jaminan kualitas.
INDUSTRI FARMASI INDUSTRI FARMASI
All parts of pharmaceutical quality systems should be adequately resourced with competent personnel and have adequate and sufficient premises, equipment and facilities. A quality manual or equivalent documentation should be prepared, which should contain a description of the quality management system, including management responsibilities.
BANGUNAN-
Where possible, starting materials should be purchased directly from the manufacturer of the starting material.
CARA PENYIMPANAN DAN PENGIRIMAN OBAT
Penyimpanan dan pengiriman merupakan bagian penting dari kegiatan dan pengelolaan rantai pasokan obat yang terintegrasi. Dokumen ini menguraikan langkah-langkah yang tepat untuk membantu memenuhi tanggung jawab semua orang yang terlibat dalam aktivitas pengiriman dan penyimpanan produk. Dokumen ini memberikan pedoman penyimpanan dan pengiriman produk jadi dari industri farmasi ke distributor.
YANG BAIK
GOOD STORAGE AND DISPATCH PRACTICES
Pharmacopoeia and other requirements current national regulations regarding labels and containers must be respected at all times.
QUALITY CONTROLPENGAWASAN MUTU
All these procedures must be carried out in accordance with written procedures and recorded as necessary. The level of control should be commensurate with their use and available stability data. This collection material must be used for the purpose described in the relevant monograph, unless otherwise authorized by Badan POM.
The size of the inoculum used in the positive controls should correspond to the required sensitivity. The results of ongoing stability studies should be available at the manufacturing site for review by the Badan POM. The original validation of the test method should be reviewed to ensure compliance with current requirements.
Self-examination should be carried out regularly and can also be carried out on special occasions, e.g.
SELF INSPECTION, QUALITY AUDITS AND SUPPLIER’S
Tujuan dari inspeksi mandiri adalah untuk menilai apakah seluruh aspek produksi dan pengendalian mutu di industri farmasi mematuhi peraturan CPOB. Program inspeksi mandiri harus dirancang untuk mengidentifikasi kelemahan dalam penerapan CPOB dan menentukan tindakan perbaikan yang diperlukan. Inspeksi diri sebaiknya dilakukan secara independen dan rinci oleh pejabat perusahaan yang kompeten dan dapat menilai pelaksanaan CPOB secara obyektif.
The purpose of self-inspection is to evaluate the manufacturer's compliance with GMP on all aspects of production and quality control. The self-inspection program should be designed to detect any deficiency in the implementation of the GMP and to recommend the necessary corrective actions. Self-inspection must be carried out in an independent and detailed manner by designated competent person(s) of the company and who can objectively evaluate the implementation of GMP.
The procedure and data for self-inspection should be documented and there should be an effective follow-up program.
AUDITS & APPROVALINSPEKSI DIRI, AUDIT MUTU
Inspeksi diri harus dilakukan secara teratur dan, terlebih lagi, dalam situasi khusus, misalnya dalam kasus penarikan obat jadi atau penolakan berulang kali.
DAN AUDIT & PERSETUJUAN PEMASOK
Management sajjai tim inspeksi diri yang samajek dalam pehgannya masing-masing and understand CPOB. They must be examined at intervals following a predetermined schedule to verify their compliance with the principles of Quality Assurance. Management should appoint a self-inspection team composed of experts in their fields and familiar with good manufacturing practices.
Company management should evaluate the self-inspection report and take corrective action if necessary. To protect public health, a system and appropriate procedures should be in place to record, assess, investigate and review complaints, including potential quality defects, and to effectively and promptly recall drugs and investigational drugs from the distribution network if necessary. The principles of quality risk management should be applied in the investigation and assessment of quality deficiencies and in the decision-making process regarding corrective and preventive measures for product recalls and other risk reduction measures.
All relevant competent authorities should be notified in a timely manner in the event of a confirmed quality defect (faulty manufacturing, deterioration of product quality, detection of falsification, non-compliance with marketing authorization or product specification file or any other serious quality problem) with the medicinal product or investigational medicinal product for a clinical trial that may result in a product recall or unusual supply restriction.
KELUHAN DAN PENARIKAN PRODUK
Untuk melindungi kesehatan masyarakat, sistem dan prosedur yang memadai harus tersedia untuk mencatat, menilai, menyelidiki dan meninjau keluhan, termasuk potensi cacat mutu, dan, jika perlu, segera dan efektif menarik produk obat, termasuk produk obat untuk uji klinis, dari saluran distribusi. Prinsip-prinsip manajemen risiko mutu harus diterapkan pada investigasi, penilaian cacat mutu, dan proses pengambilan keputusan terkait penarikan produk, tindakan perbaikan dan pencegahan, serta tindakan mitigasi risiko lainnya. Semua otoritas pengawas obat yang relevan harus diberitahu secara tepat waktu jika terdapat cacat mutu yang dipastikan (cacat produksi, cacat produk, deteksi pemalsuan, ketidakpatuhan terhadap izin edar atau spesifikasi produk, atau masalah mutu serius lainnya) dalam suatu produk obat. atau uji klinis produk obat yang dapat mengakibatkan penarikan produk atau pembatasan pasokan.
Apabila diketahui suatu produk yang beredar tidak memenuhi izin edar, maka wajib dilaporkan kepada Badan POM dan/atau badan pengawas obat terkait, sesuai ketentuan yang berlaku. Dalam hal kegiatan outsourcing, kontrak harus menjelaskan peran dan tanggung jawab produsen, pemegang izin edar dan/atau sponsor dan pihak ketiga terkait lainnya sehubungan dengan penilaian, pengambilan keputusan dan penyebaran informasi dan implementasi. Dalam situasi dimana ditentukan bahwa suatu produk di pasaran tidak sesuai dengan izin edar, maka perlu memberitahukan kepada Badan POM dan/atau pihak berwenang terkait sesuai dengan persyaratan hukum yang relevan.
In the case of outsourced activities, a contract must describe the role and responsibilities of the manufacturer, the marketing authorization holder and/or sponsor and any other relevant third parties in relation to assessment, decision-making and dissemination of information and.
COMPLAINTS AND PRODUCT RECALL
All complaints should be documented and evaluated to determine whether they represent a potential quality defect or other problem. In particular, other batches which may contain parts of the defective batch or defective components should be investigated. These should be considered on a case-by-case basis and discussed with the relevant competent authorities.
Complex systems must be understood, well documented, validated and appropriate controls in place. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period. There should be a system to indicate special observations and any changes to critical data.
KEGIATAN ALIH DAYA OUTSOURCED ACTIVITIES
There must be a written contract between the Contractor and the Contractor that clearly establishes the roles and responsibilities of each party. The Pharmaceutical Quality System of the Contractor must clearly indicate how the Head of Quality Assurance who certifies each batch of product for release exercises his/her full responsibility. The Contractor is ultimately responsible for ensuring that processes are in place to ensure the control of outsourced activities.
The contractor is also responsible for ensuring through the contract that the principles and guidelines of GMP as interpreted in this guide are followed; The client must ensure that the contractor is fully aware of any problems. Arrangements made between the contractor and a third party must ensure that information and knowledge, including that resulting from assessments of the third party's suitability, is made available in the same way as between the original client and the contractor.
The technical aspects of the contract should be drawn up by qualified persons with adequate knowledge of related outsourced activities and good manufacturing practice.
KUALIFIKASI DAN VALIDASI
QUALIFICATION AND VALIDATION
ANNEX 1
PEMBUATAN PRODUK STERIL
MANUFACTURE OF STERILE
MEDICINAL PRODUCTS
To meet the "operating" conditions, these areas must be designed to achieve certain specified levels of air cleanliness in the "rest" state. A grade A area should be monitored so frequently and with an appropriate sample size that all The importance of a particulate monitoring system should be determined by the separation efficiency between adjacent Class A and Class B zones.
Monitoring of Class C and D operating areas should be carried out in accordance with the principles of quality risk management. The isolator and the background environment must be designed in such a way that the required air quality for the individual areas can be achieved. Monitoring should be performed regularly and include frequent leak testing of the isolator and glove/headgear system.
Equipment used for the production of products for terminal sterilization must be installed in at least a class D environment.
