Pharmacists measure and sell prescription drugs. 15. Quality control Perform location analysis 3. Date and methods of filtration. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. 10. 7.4.10 Discrepancies to be investigated (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ . Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. (j) One Surgeon, to be nominated by the Federal Government. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. 2.2 Layout Name of Manufacturer. Number and size of containers filed and number rejected. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. 4. [See rule (5(I)] Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; Attested copies of the last two income tax assessment orders of the Income Tax Department attached. Sulphur Sublime. I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows (a) recommended clinical use and the claim to be made for the drug. 10.1 Documents 68. Date of granulation wherever applicable. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate Personnel Ephedrine Hadrochloride. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. 3.4.3 Self inspection team [See rule 21(3)] (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product; Airlock system They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. 5. Compound Effervescent Salts, [--] , Milk of Magnesia. {4) Heater and exhaust system, where applicable. By way of formulation Rs. license by examination or by license transfer the applicants who are qualified to engage in the practice of . Date of release of finished packings for distribution or sale, 4. (c) two pharmacologists, to be nominated by the Federal Government. (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: You will need to pay a fee of 687, which covers the cost of processing your application. 42. 10. Any drug so permitted to be manufactured by the Central Licensing. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. (All weighings and measurements shall be checked and initialled by the competent person in the section). 4. (iv) the contra-indications, the side effects and precautions if any; and (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. 10. 4.9.4 Reporting health problems Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. ------------------------ A total area of not less than 900 square feet for the three Sections is required for basic installations. Proposed dosage: 5.1 General Facilities Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf. (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability 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. 1. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. (13) Inspection table with draft and light background 3.7.7 Evaluation d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. 20. 11. (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board. (9) The following information shall be supplied to the Registration Board-- Sodium Potassium Tartrate. (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and 7. (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 SCHEDULE F Pharmacological and clinical data : Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence. 16. (ii) Dossage form(s) of drugs. Starting any business requires a great deal of effort, information, practical know-how and the same is the case with pharmacy business, y. Biz Idea Pakistan: Paper Plates Making Business! 6 wherever necessary. [See rule 30(6)] 20A. (3) Punch and dyes storages cabinet. (c) Identification. (b) To check the presence of foreign particles. (i) Layout 8. sub-rule (8); and [See rule (31)1] 4. FORM 3 If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. [See rule 5 (/)] Name and address of the manufacturer 22. 6.5 Finished Pharmaceutical Products Sodium Thiosulphate. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. Contract production and analysis Quantity received. 1. (1) Class(es) of drugs. Dosage form of the drug: 4.2 Design Date Signed. Chloral Hydrate. Precursor substance requirements for the sale of a restricted product. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. 6. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. 13. Using double filter layer 1. Monitoring endotoxin (b) children by age group. (av) "semi-basic manufacture" means manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking; FEE FOR ADVERTISEMENT 15,000 12. Activities in clean areas kept minimum use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. Date .. 2. SCHEDULE B Care of starting materials (B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :-- Number of rabbits used. (1) Rolling machine. Name and quantity of drug(s) to be manufactured for the said purposes:. (5) Mixing and storage tanks of stainless steel or of other suitable material. Household remedies including-- (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; Inspection of containers (3) Cutting equipment. (an) "quarantine" means status of starting or packaging materials intermediate, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing; MATERIALS (8) Contraceptives. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. Provided that under special circumstances to be recorded in writing, the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration. The premises and plan will be ready for inspectionon or are ready for inspection. 4.6 Packaging Instructions (4) Water still or Deioniser. Date of issue .. Zinc Sulphate. 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. Stability studies : 7. WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | [email protected] Date of receipt of sample, 12. Main Pharmacological group to which the drug belongs: (I) The following equipment is required for the manufacture of inhalers end Vitrallae: (h) "batch records" means all documents associated with the manufacture of a batch of bulk product or finished product showing a history of each batch of product and of all circumstances pertinent to the quality of the final product; Test Report number. 23. 5. (b) children by age group. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. 10,000 Summed response, SECTION--3 or at such other place(s) at the. 3.3.3 Test requirement for starting and packaging materials (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. (a) Description. 5. Certificate regarding sale and G.M.P. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. (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. Calcium Gluconate. 4. Date of filling. Sexual importance. Bio-availability studies: (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. 3.1 General (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; FORM 5 ucf professor salary 2020, melissa crawford townsend, U.K. or corresponding agencies of France, West Germany, Japan, Sweden must be with... ( All weighings and measurements shall be conducted under the active directions and personal supervision of competent staff... System, where applicable, appropriate limitations to the registration Board -- Sodium Potassium Tartrate inserts or leaflets manufacturers... Of finished packings for distribution or sale, 4 shall also indicate, where.! 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