Sera. 29. Name(s) of Proprietor(s)/Director(s)/Partner(s). (vi) Environmental Controls 5. 7.1.7 Unauthorized entry prohibited Ferric Ammonium Citrate. (ak) "purity" means the degree to which other chemical or biological entities are present in any substance; 4. 2. 57. (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; ----------------------- Serial number. 17. 7.1 Processing operations 34. 1362(I)/96-28.11.96). (ii) Details of the premises including layout plan of the factory. 6.2.4 Damaged container SECTION-2 (ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates. SECTION-I I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. (7) Liquid filling equipment. 8. 6. (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. 2, Name of drug DETAILS OF THE FIRM 6.1.1 Quarantine 4.9.4 Reporting health problems 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. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS Serial Number. Use of disinfectants and detergents General Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and 4. The application fee is $147. Remarks. (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. 10.1.7 Specification approvals (5) Mixing and preparation tanks or other containers. 7.2.3 Cross contamination checks 2.8 Defective Equipment (3) Sifter or sieve. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. Number of mice used and weight of each mouse, Strength and volume of the drug injected, Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. Protocols of tests applied: sub-rule (8); and 1. (iv) licence to manufacture by way of repacking; and 19. _________________________ (2) Graduated delivery equipment for measurement of the medicament. If you have an active intern registration in Kansas, you may only need to pay $100. Date of Registration Secretary Registration Board (Seal) Chairman. Market your pharmacy 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:- 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. 4.9 Personal hygiene 10.4.10 Equipment utilization record Invoice/Challan number and date. Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). Patent number, if any, with date and its date of expiry : Name of the sample. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and Name of Drug(s). (7) Liquid filling equipment. (b) the content of active ingredient(s) per dosage form or regimen; Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 4. 9.2 Process validation 6.1 Rest Rooms Licensing Authority. Fish Liver Oil and its equivalents. Filter safety B. Parenteral preparation: 66. Normal temperature of each rabbit. [See rule 26(I)] 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. 8. Use of vacuum (5) The manufacture of any drug shall not, without the prior approval of the Registration Board, be discontinued for period which may result in its shortage: (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: (ii) Tableting Section; 3. 67. Maintenance of equipment Name(s) of the drug(s): 18. It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. (a) That licensee shall use the drugs manufactured under the licence exclusively for experimental purposes and shall carry on the manufacture and experimental work at the place specified in the licence. Name, address and status of the applicant: 4.3 GMP awareness 1.Analytical report number Finishing of sterile products 20. 35. (c) Any other tests (8) Hot Air Steriliser, This sort of license may be found here. (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR 32. 7. 6.9.4 Storage SECTION -- 7 State Board of Pharmacy. Drug Regulatory Authority of Pakistan. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION SCHEDULE B I-A. (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; RESPONSIBLE PERSON REQUIREMENTS FOR LICENSURE Updated 12/5/2022 Pursuant to rules 4729:5-2-01 and 4729:6-2-01 of the Ohio Administrative Code, the Board . (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. 3.5.2 Suppliers audits 6.3.5 Checking before delivery In Pakistan a person who has following qualification will be considered as an eligible candidate for course of pharmacy technician; Matriculation with science from a recognized institute of Pakistan. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. 27. SECTION--3 3.6.2 Person authorized 4. (a) rupees one thousand for the registration of new drug; (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 9. In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. 51. (ar) "retail sale" means a sale other than wholesale; Chloral Hydrate. 1 2 3 (b) Identification. 3. 3. Sterilization of gases used 2. 16. 30. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. Register Lost your Password? 1.1 Responsibility of licensee for drugs fitness for use. 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. Captcha: 9 + 4 = Sign In. 4.1 General 38. 1. 6.4.2 Handling 3.6.6 Follow-up action 6. Registration Board: (1) The Registration Board shall consist of such members, including the (6) A triple-roller mill or an ointment mill, where applicable. 35. (3) Polishing pan, where applicable, (iv) Services For assistance with licensing, please . 6.6.1 Storage and disposal Bismuth Subnitrate. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :-- Iodine. 7. 6. [See rule 26(3A)] Antitoxins. 9. Date of receipt of sample, (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. An area of minimum of 300 square feet is required for basic packing operations. 8. 3.6.3 Written procedures (2) Stainless steel scoops end vessels. 7. Signed Kaolin. (ii) a degree in science with chemistry or pharmaceutical chemistry as the principal subject who, for the time being is working as incharge of a licensed pharmaceutical manufacturing unit, has not less than ten years practical experience in the manufacture of drugs intended to be manufactured knowledge of pharmacy which, in the opinion of the Central Licensing Board is adequate for the purposes; or (i) Class(es) of drugs. Justification : Household remedies including-- 40. 21. 13. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' _________________________ (b) children by age group. (i) enclose certificate of registration and Free Sale from any of the following countries: Rs. Ephedrine Sulphate. 3. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. (a) Preparations of the container: This includes, cutting. Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund; Certificate regarding sale and G.M.P. 3.6.4 Recording defects and investigation 3.6.1 Review of complaints (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. Click GO on the Apply/Manage a License and Service Requests tile. Salicylic Acid. (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool 3.7.1 System (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. 13. Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . (iv) hygienic garments shall be worn by all staff in processing and packaging areas; (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. 6. Procedure Pharmacy licensing. [See rule 5 (2)] 10,000 Sufficient water must be available for fire-fighting. (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); Antigen. Dates of coating wherever applicable. (ah) "pharmaceutical product" means any drug intended for human use or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form; Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed). 10.1.4 Status identification HTML PDF: 246-945-245: Health care entity license. 7.4.2 Pre-packaging checks Simulation of aseptic operations validation (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. The room shall be air-conditioned and also dehumidified wherever necessary. SCHEDULE G (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; Date of issue .. 3.6.7 Recording measures (d) Omitted by S.R.O. 7.2.4 Microbiological monitory Ensure contact between gas and microbial cells (iii) Surfaces Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : (b) Preparation of solution: This includes preparation and filteration of solution. P.O. (ii) Details of the premises including layout plan of the factory. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. 4.7 Standard Operating Procedures (SOPs) and Records Sufficient time allowed to reach required temperature Processing (k) One physician, to be nominated by the Federal Government; Monitoring endotoxin (A) For the grant of Registration Rs. Boric Acid. (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; Sign in to start your session. Validation 17. (a) Description. Location and Surroundings . 8. 18. (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. 4.8 Packaging Materials DOCUMENTATION 2. 3. Pharmacy Services Health Department KP. 1. (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. 7.4 Packaging operations 28. (d) name of manufacturer or distributor. Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : 3.3.6 Production record/batch review [See rule 16 (bb)-7] of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. _________________________ FEE FOR ADVERTISEMENT 7.2.2 Measures against contamination 12,500 12. 12. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. 10,000By way of semi-basic Rs. 25. Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. (a) for adults. 5 wherever necessary. 3, Batch Size, 9. Sodium Metabisuphite. (1) Mixing tanks where applicable: (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; wherever necessary (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. Protocols of tests applied (au) "Schedule" means Schedule to these rules; The License can be renewed as it is valid for up to five years. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. A total area of not less than 900 square feet for the three Sections is required for basic installations. (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; Hygiene and cleanliness General 2. 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. 4.7 Special Materials Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. 2. 13. Pharmacological group _________________________ Profit and loss statement as per audited accounts for the last five years : Ferrous Sulphate. 3.7.3 Written procedures 11. (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: Monitoring each cycle Care after final cleaning of materials 4.3 Bays (ii) Cost of each packing material. LICENCE TO MANUFACTURE DRUG(S) 6, Results of tests applied. 1.1 Location 1. (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. 36. Licensing Requirements. degree program in the United States requires at least 2-years of specific pre-professional (undergraduate) coursework followed by 4-academic years (or 3-calendar years) of professional study. 5.2 Dedicated Facilities for Production E. Container, packing material, etc. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. Procaine Hydro-Chloride. 10.1.1 Maintenance of documents 10.3.1 General While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. 6.6.2 Reprocessing 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. (b) the Director, Health Services of, each Provincial Government; Manufacture of sterile preparations Pharmacy Technician Registration Requirements & Application (online application) 2.2 Terminally sterilized products (2) The preparation room where the solution ate prepared shall be of such a nature that may be kept scrupulously clean. Sterility test reference on bulk batch wherever applicable. Suitability of process (f) side-effects and major adverse drug reactions; (i) Granulating Section; 2.3 Products sterilized by filtration (c) toxicity or the side-effects. (a) Description. (b) Shelf-life when stored under expected or directed storage conditions. Graduates Pharmacist Licensure by Endorsement for Non-U.S. Asepsis of articles in clean areas 5.1 Sanitation SCHEDULE B-II General 4.4 Quarantine 18. Outside contractor 3. For Foreign-trained Pharmacy Graduates / Pharmacists. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. (i) licence to manufacture by way of basic manufacture. Use of protective garments 6.10.1 Storage (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. General Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. 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