39. 3.1 The contract acceptor shall not pass to a third party any of the work entrusted to him or her under the contract without the written consent of the contract giver and prior evaluation and approval by the arrangements of the Central Licensing Board, and arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor. 6.9.2 Use to be nominated by the Federal Government. CHAPTER I - PRELIMINARY (b) Shelf-life when stored under expected or directed storage conditions. In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- (3) Cutting equipment. Register Lost your Password? 5. Name of the sample (iii) licence to manufacture by way of formulation; (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. Asepsis of articles in clean areas 4.8 Training 6.5 Finished Pharmaceutical Products Rs. Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. Signature of the expert staff responsible for manufacture. 26. Sanitation Washing of clothing 9. (3) Punch and dyes storages cabinet. Entry restricted Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. 6.9 Reference standards Verification can be emailed Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. 17. Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. (All weighings and measurements shall be checked and initialled by the competent person in the section). 16. 11. 7.1.3 Avoiding deviation Name of the material Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. 2.3 Construction APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container. [See rule 31 (10)] Licence to Manufacture Language which brings about fear or distress shall not be used. Name(s) of Proprietor(s)/Director(s)/Partner(s). 16. (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply. 2,500 The Tableting Section shall be free from dust and floating particles. (c) For pyrogens wherever applicable. (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- FORM 6 General (Signature of designated authority (Place and date) (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. 4.10 S.O.Ps Miscellaneous 32. 3.6.1 Review of complaints 20A. Sulphonilamide Powder (B. VET. 14. SECTION--3 4. Simulation of aseptic operations validation (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. (5) Various liquid measures and weighing scale. Analgesics: PREMISES Total. 3. Filling and Sealing Room: Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. 24. 6.6.1 Storage and disposal 9. (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. If it is not possible, the reasons therefor. Batch number. 7. DOCUMENTATION 10,000 General 4. DRUGS FOR REPACKING C). 18. 2. 3.3.6 Production record/batch review Date of commencement of manufacture and date of completion. (2) Kettle, gas or electrically heated with suitable mixing arrangement. sealing unit, (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; Interval between operations to be minimal 8. 7.4.10 Discrepancies to be investigated (i) Sodium Potassium Tartrate. 7. Kaolin. 7.4.11 Destruction of un-used packaging materials Sena. 35. 4.7 Duties of Quality Control Incharges (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: Dosage from of the drug: Validation SECTION -- 7 11. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. (k) One physician, to be nominated by the Federal Government; Name of the Firm. Serial number. ------------------------ Ammonium Chloride. Handling procedures Captcha: 9 + 4 = Sign In. 30. (iv) licence to manufacture by way of repacking; and Magnesium Sulphate. Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. Countersigned by .. (g) Toxicity test, wherever applicable. (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. Name of drug, under which it is proposed to be sod: 7. Serial number (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; 3. B.S. (See rules 19 and 30) Harrisburg, PA 17105-2649. (d) name of manufacturer or distributor. (5) Mixing and storage tanks of stainless steel or of other suitable material. Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2. Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . Sodium Bicarbonate. 4. 2. (f) side-effects and major adverse drug reactions; Information on price to the consumer shall be accurately and honestly portrayed. 7.4.2 Pre-packaging checks Date .. 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