To organise lecture series by experts drawn from Industry and academia in the relevant areas of training.

Transcription

1 CSIR-IIIM Skill Development Programme Current Good Manufacturing Practices (cgmp) of Botanicals/ Herbal Drugs/Phytopharmaceuticals (Three Months PG Certificate Course) Introduction CSIR- Indian Institute of Integrative Medicine is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). IIIM is a multidisciplinary organization encompassing the natural products chemistry, medicinal chemistry, pharmacology, microbiology, biotechnology, chem.-informatics and botanical sciences. The mandate of CSIR-IIIM is to be an internationally competitive centre of excellence in all facets of natural products research and technology, including (a) discovery of novel pharmacologically active natural products from plants and microbial species and translating them into drug leads and candidates by medicinal chemistry, preclinical pharmacology and clinical development. This approach is pursued both in new chemical entity as well as botanical herbal mode; (b) Preclinical and clinical validation and establishment of mechanism of action of drugs used in various Indian systems of Medicines (Ayurveda, Unani, Siddha and other Indigenous systems of medicine); (c) develop agro-technologies and commercial cultivation of high value medicinal and aromatic plants from Western Himalayas including Kashmir Valley and Laddkh for national and international markets; and (d) to work with Indian and global pharmaceutical industry to out-license new products and technologies. Institute is open to students from across the country to register themselves for Ph.D degree in biological and chemical sciences. Currently more than 200 students are pursuing their Ph.D s in biological & chemical sciences. Recently at IIIM, Jammu a state-of-the-art unit for manufacture of herbal drugs has been established as a National Facility for small and medium scale manufacturers from north India and the state of J&K. The facility has been created with the financial support of Department of Science and Technology (DST), Council of Scientific and Industrial Research (CSIR) and Dept. of AYUSH Govt. of India and has been granted license by the J&K state regulatory authority (Food and Drug Control Organization) under License number JK/01/14-15/AY- UN/216, Dated: 30/01/2015 under Schedule T, Drug and Cosmetic Act 1940). The facility is conceived to provide leadership in phytopharmaceuticals and other allied subjects. The Unit has been also granted license for the manufacture cum marketing of plant based drug formulations. CSIR IIIM intends to start a three month post graduate diploma course open to science (B.Sc./M.Sc.), pharmacy (B.Pharm/M.Pharm) and medicine (MBBS/ BAMS/ BUMS/ BHMS) graduates. This dedicated centre aims at creating synergy between industry and academia. It will cater to the requirements with respect to training on good agriculture and collection practices (GACP), current Good Manufacturing Practices (cgmp), good documentation practices (GDP), QC/QA-CMC and regulatory aspects related to production of botanical/herbal formulations. Separate modules for practical training on analytical instruments, GMP based preparation of extracts and formulations, will be the integral part of

2 this course. During the course, students will get a chance to listen to series of lectures and interact with experts from industry and academia. Objectives: The main objective of CSIR- IIIM is to conduct three month diploma course to create a stream of highly trained manpower by enhancing practical and regulatory skills of science, pharmacy and medicine graduates in the area of extraction and formulation of herbal / botanical drugs. This experience shall enhance their employability by potential employers in the field of phytopharmaceuticals or allow them to set up their own pharma enterprises. To develop training programs to match the requirements of the Pharma/ phytopharmaceutical sector covering production, regulatory, quality control / quality assurance (QC/QA) and chemistry, manufacture & control (CMC) aspects. To utilize the expertise available with the faculty members of CSIR-IIIM in solving specific problems of trainees in the area of production, quality control and CMC etc. To organise lecture series by experts drawn from Industry and academia in the relevant areas of training. Areas to be covered: Good Agriculture and Collection Practices for medicinal plants, their authentication using macroscopic, microscopic and molecular (DNA bar code) markers. Accession of authenticated materials in Herbarium/ Crude Drug Repository along with passport data. Storage, drying and post harvest techniques. Training in the extraction methods (alcoholic, hydro-alcoholic, aqueous, and Super Critical) at laboratory and pilot scale (GMP/ nongmp mode). Raw material testing parameters (QC/QA and CMC). Regulatory aspects for development of botanical drugs / Phytopharmaceuticals. Preparation cum development of formulations of active extracts (APIs) in the form of tablet, capsule and syrups. Packaging and labelling of the finished marketable botanical/ phytopharmaceutical products. Calibration, trouble shooting, software handling of instruments / equipment. Preparation and submission of applications to State Regulatory Authority (DFCO) / DCG(I) for approval of herbal/ phytopharmaceutical products for production and/or marketing.

3 Qualification : Graduate in science (B.Sc./M.Sc.), pharmacy (B.Pharm/M.Pharm) and medicine (MBBS/BAMS/BUMS/BHMS), with minimum 50% aggregate in Science with Chemistry as one of the subjects, (For SC/ST candidate : 45%) Admission Criteria : Admission shall be purely on merit & first come first serve basis. Sponsorship: Established industrial houses are welcome to sponsor candidates of their interest. In the selection modality, a special weightage will be given to the candidates sponsored by established industries and non-profit making social organizations, provided they fulfil minimum essential qualifications. Batch size: In each batch 25 students will be admitted on first come first serve basis. Fee Structure: Rs. 50,000/- per students for complete course (in three equal instalments). Fee is inclusive of: Boarding & lodging for three months (students will be provided hostel accommodation on twin sharing basis). Study material. Visit to local Pharma Industry Training module and time schedule for the PG Diploma in cgmp: 1. Raw Material Controls (Procurement of raw drug material): (1-15 Dec,2017) i) Good agriculture and collection practices (GACP) ii) Post harvest handling and storage of medicinal plants iii) Authentication of crude drug materials using macroscopic, microscopic and molecular techniques. iv) Accession of crude drug samples in herbarium and crude drug repository v) Concept of Chain of custody for procured herbal drugs vi) Passport data sheets for procured drug material. vii) QC/QA of crude drugs 2. In Process Controls (extraction, drying, packaging and QC/QA) : (16 Dec, Jan., 2018) Under this module the trainees will be exposed to the following: Raw material handling and storage in GMP facility Grinding and sifting of raw material Cleaning of equipments Raw material quality check and QA clearance Raw material testing parameters (Chemistry Manufacturing Controls) as per the Ayurvedic Pharmacopeia of India. Conventional and non conventional extraction methods and types of extraction processes (to alcoholic, hydro-alcoholic, aqueous and Super Critical) Drying of extracts (pan drying, freeze drying, and/or Spray drying).

4 Check list clearance as per Quality Assurance/Quality Control parameters Testing parameters of API (extract) as per the Ayurvedic Pharmacopeia of India or their official Monographs and CMC thereof. Packaging conditions of the extract powder. SOP (standard operating procedures) driven hands on the training on the following machines/ equipments/instruments. Operation of extraction plant through automated / manual mode. Extractor cum distillation Distillator Wiped film evaporator Vacuum pan dryer Vacuum tray dryer Spray dryer Plant material tray dryer Grinder Vibro sifter 3. Formulation Preparation Controls (tablets, capsules and syrups, QC/QA): (11-31 Jan., 2018) Under this activity the trainees will be exposed to various processes involved in formulation designing and development of tablets, capsules and syrups. A: Tablet section: Training module includes: Receiving and storage of raw material (excipients and APIs) Man and material entry procedures Quality Assurance/Quality Control, Raw material and API extract clearance /quality check Tablet preparation Tablet making IPQC Coating of tablets Packaging (strip and blister) SOP (standard operating procedures) driven hands on the training on the following machines/ equipments/instruments. Rapid mixer granulator Tablet comprehension machine Tablet inspection belt Fluidized Bed dryer Bin Blender Auto coater Strip packing machine Roller compactor B: Capsule section: Training module includes: Receiving and storage of raw material (excipients and APIs) procedures

5 Man and material entry procedures Quality Assurance/Quality Control, Raw material and API extract clearance /quality check Capsule preparation Capsule making IPQC Capsule filling and sealing (Semiautomatic capsule filling) Packaging (strip and blister) SOP (standard operating procedures) driven hands on the training on the following machines/ equipments/instruments. Semi-automatic capsule filling and sealing machine Capsule polishing machine Blister packing machine Roller compactor C: Liquid oral section: Training module includes: Receiving and storage of raw material (excipients and APIs) procedures Man and material entry procedures Quality Assurance/Quality Control, Raw material and API extract clearance /quality check Syrup preparation Syrup making IPQC Bottle washing Bottle filling & sealing Packaging SOP (standard operating procedures) driven hands on the training on the following machines/ equipments/instruments. Liquid online preparation tank Bottle washing machine Automatic bottle filling, sealing and labelling machine Cap sealing machine Bottle inspection table 4. Quality Assurance/Quality Control (QC/QA): (1-15 Feb.,2018) It is an essential component for the manufacture of botanical /Phytopharmaceutical products starting with raw material to the finished marketable products. This process includes important components such as authentication of the raw materials based on marker compounds, chemistry manufacture and control (CMC), and maintenance of regulatory standards. The trainees shall be exposed to the following subjects: Ascertaining the quality parameters of raw materials and finished products (CMC, hardness, friability, dissolution, disintegration, etc.) Stability evaluation

6 SOP driven hands on the training on the following machines/ equipments/instruments. High-performance liquid chromatography (HPLC) Inductively Coupled Plasma Mass Spectrometry (ICPMS) Liquid Chromatography Mass Spectrometry ((LC-MS/MS) Gas Chromatography-Mass Spectrometry (GC-MS/MS) Gas chromatography (GC) Infrared spectroscopy (IR) Ultraviolet- Visible spectroscopy (UV-Visible) High-performance thin layer chromatography (HPTLC) Dissolution and Disintegration apparatus Wet lab Stability chamber & stability testing Microbiology section Qualification instruments and machineries like DQ, IQ, OQ, PQ Dissolution testing & Stability testing Calibration of Instruments. All the trainees will be asked to give their choice with respect to any three of the following divisions/ sections/ facilities of the Institute for rotation for a period of 1 week each. 5. Utilities and Services: (16-20 Feb., 2018) In this section the trainees will be acquainted with the following essential utilities and services required for optimal operation of cgmp facility. Types of water used in the pharmaceutical industry (Raw water, purified water, RO water and water for injection). Disposal and management of waste water and chemicals (ETP, soakage pit etc) Air handling unit (AHU) and classification of filters in the HVAC system. Role of compressor and boiler in pharmaceutical industry. 6. Regulatory aspects: (21-24 Feb., 2018) Preparation and submission of applications to State Regulatory Authority (DFCO) / DCG(I) for approval of herbal/ phytopharmaceutical products for production and/or marketing. IND filing DCG(I) / AYUSH regulatory mode (schedule-y) Drugs & Cosmetic Act & their Rules-1945 Rules to get product permission on classical / non classical drugs Study visit to local Pharma Industry 7. Final evaluation: (25-28 Feb.,2018) Submission of work report for evaluation Final Exam Award of completion certificate