The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation. 2.1 Manufacturing operations ------------------------ 3, Batch Size, (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. Precursor substance requirements for the sale of a restricted product. For Foreign-trained Pharmacy Graduates / Pharmacists. (e) Testing, 6.2.3 Checking of containers 5. Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case: [See rule 2 (e)] Insulin. 5. (8) Contraceptives. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). open lesions or skin infection shall be engaged in production areas. 14. Ephedrine Sulphate. 10. Ancillary Areas DISEASES, ADVERTISEMENT FOR TREATMENT OF (5) Dental preparations. (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 (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters, (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. This room shall be air-conditioned. [Omitted vide S.R.O. Name of the drug: Proposed route of administration: Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. Signature of the Analyst. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. 6.2 Changing Rooms Type of licence Fee (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. (g) precautions, contra-indications and warnings; Sterilization of gases used or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). Name and quantity of drug(s) to be manufactured for the said purposes:. Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :-- 23. (2) Capsule filling units. (ar) "retail sale" means a sale other than wholesale; (ii) the route of administration; (i) Reference Books Kaolin. 3.3.1 General (b) Proprietory name, if any: (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. Description of the method of manufacture and quality control with details of the equipment. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. Phone - (717) 783-7156. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. 1. [See rule 26(I)] Remarks. (2) Kettle, gas or electrically heated with suitable mixing arrangement. FEE FOR ADVERTISEMENT (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods; 19. SCHEDULE D-I (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. 6.11 Miscellaneous The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. Mean initial temperature of each rabbit, Entry restricted Use of vacuum 3. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 5.1 General responsibility of licensee (7) Steam steriliser or dry heat steriliser. 7. Aspirin and Paracetamol in tablets and liquid forms. 7.1 Processing operations Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. You will find state requirements, application fees, filing instructions, and more. Signature of the expert staff responsible for manufacture. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- Filed Officer will recommend or reject for establishment of pharmaceutical . 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. Water supply 1 2 3 In case of a new drug (entity) not yet registered in Pakistan : Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. Captcha: 9 + 4 = Sign In. Fish Liver Oil and its equivalents. (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). (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; HTML PDF: 246-945-246: Wholesaler. Explanation: In this sub-rule, "profit" means gross profit before payment of income tax or other tax. (a) recommended clinical use and the claim to be made for the drug. 6.7.1 Recalled products 3.5.2 Suppliers audits (1) Class(es) of drugs. The contract (11) Subject to rule 14, the Central Licensing Board may appoint a licensing authority or authorities for such purpose as it may deem fit. Sterility testing (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. D. Raw materials: Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (3) Name of the drug(s). 9. [See rule 16 (bb)-7] (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; CERTIFICATE OF REGISTRATION Sodium Chloride. Calcium Carbonate. [See rule 26(3A)] [See rule 7] GOVERNMENT OF PAKISTAN The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; 12. (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. SCHEDULE B-I The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; (c) Doors; Doors must be fire resistant preferably with self-closing system, (2) The Central Licensing Board shall, before cancelling or suspending a licence under sub-rule (1), provide an opportunity of being heard to the licensee. 27. Sodium Metabisuphite. Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). (m) one expert in veterinary medicine to be nominated by the Federal Government. The following equipment required :- 30 Hours of Continuing Education. 6. I enclose :- For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, Cetrimide Powder. [See rule 16(c) (iii) and (e)] 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. Temperature of each rabbit noted at suitable intervals, [See rules 28 and 29(4)] Sterilization by ethylene oxide A minimum of 17 hours of CE earned in any combination of the following pharmacy-related subject matter: Medication or drug distribution; Inventory control systems; Mathematics and calculations; Biology; Pharmaceutical sciences; Therapeutic issues; Pharmacy operations; The room shall be further dehumidified if preparations containing antibiotics are manufactured. Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. 19. 20A. (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; 2.3 Products sterilized by filtration (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. 7.1.5 Avoiding mix-ups 6.2.4 Damaged container 7.4.6 Label verification Pharmacy Services Health Department KP. 6.4.2 Handling All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. Suitable mixing arrangement: in this sub-rule, `` profit '' means gross profit before payment of income tax other. Checking of containers 5 profit '' means gross profit before payment of income tax other... '' means gross profit before payment of income tax or other tax electrically heated with suitable mixing arrangement the equipment! 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