Name and address of the manufacturer (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; Hygiene and cleanliness Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and (All weighings and measurements shall be checked initiated b the competent person in the section). (2) They shall come into force at once. 23. 4.5 Master Formula (b) rupees five hundred for the registration of any other drug; and PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. (1) Mixing equipment. The room shall be further dehumidified if preparations containing antibiotics are manufactured. (b) contra-indications. By way of repacking Rs. Clothing requirements (i) licence to manufacture by way of basic manufacture. (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. 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. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and 6.2.2 Purchase from producer or established supplier (g) any failure of one or more distributed batches of that drug to meet the required specifications; In order to avoid over-promotion, the main part of the volume of sales they generate. Resorcin. 4. 3. (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and Soft yellow Paraffin. 11. (4) Water still. (c) infant Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and-- 34. 3. Pay your fees using internationally accredited credit cards e.g. Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . 5. The application fee is $147. (3) Weighing and measuring equipment. If withdrawn from the market anywhere 50.00 stamp papers as prescribed ( Click to Download- Affidavit) Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. Ferric Ammonium Citrate. General Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 20. Cetrimide Powder. (i) Reference Books 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, (2) Trimming machine. 26. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. Personnel 1. Ingredients : ---------------------- This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. Substances Parenteral preparation in general: 20A. Records of tests employed :-- (5) The Registration Board may, while registering a drug under sub-rule (4), approve the details as supplied by the applicant or approve them with amendments as it may deem fit in respect of the following particulars, namely :-- Processing 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. Address (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation 3.4.5 Self inspection report 12. 24. 2.5 Tanks (iii) Cost of direct labour, 7.4.11 Destruction of un-used packaging materials 2. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. Number of rabbits used. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. 2.4 Piping 8. Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: 34. 4.4 Quarantine (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. 6. Sterility test as the last measures PH of the solution wherever applicable. [See rule 31 (1A) and (1B)] CHAPTER I - PRELIMINARY Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- 8. 4. The following equipment is required in each of the three sections :- (1) Rolling machine. 6.7.1 Recalled products 19. (c) toxicity or the side-effects. 1 2 3 The License can be renewed as it is valid for up to five years. This license is not granted until before inspecting the premises and consequently issuing of inspection report after which the licensing authority shall issue a license for Pharmacy or Medical Store. In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Date of release finished packings for distribution or sale. 14. 37. (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. 8. PROFORMA (i) Country. (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) 4.8.1 Written programme Licence to Manufacture Preparation of live organisms A minimum of 1 hour of CE earned in the area of pharmacy law. The importation into Panama of narcotic, controlled and restricted drugs is subject to import licensing to ensure that traders' procedures are in conformity with Panama's international obligations (Single Convention on Narcotic Drugs 1961 and Convention on Psychotropic Substances 1981). For Foreign-trained Pharmacy Graduates / Pharmacists. Control reference numbers in respect of the lot of glass containers used for filling. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. and Denmark. 30. Approval for an Innovative Pilot and Demonstration Research Project. Both are non-refundable. 3. 7. GENERAL CONDITIONS and 190.00 Renewal Fee. The Doctor of Pharmacy (Pharm.D.) The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. 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; 3. Personnel 7.4.10 Discrepancies to be investigated (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; (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and 1. contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978: RECORDS OF RAW MATERIALS 1362(I)/96-28.11.96). (j) Cost Accountant of the Ministry of Health; LICENCE TO MANUFACTURE DRUG(S) (I) The following equipment is required for the manufacture of inhalers end Vitrallae: Batch number. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. (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; Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. Sufficient water must be available for fire-fighting. QUALITY CONTROL DEPARTMENT Name and address of the manufacturer: 10.4 Batch packaging records 5. Order cabinetry 7. Zinc Sulphate. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- *The whole course must be done in the campus of the University/Country . license by examination or by license transfer the applicants who are qualified to engage in the practice of . Protocols of tests applied: SECTION -- 6 I/we.of .hereby apply for registration of the drug namely details of which are enclosed. Signature of the Analyst. 4.7 Standard Operating Procedures (SOPs) and Records 3.7.4 Recall with promptness Dosage form of the drug: 3.7.7 Evaluation Name of the sample (10) Filling and sealing unit We recommend that you send all supporting documentation to NABP at the time of submitting your application. 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. (3) Sealing equipment, Name of drug. (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; 28. This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. (a) For the grant of licence: Magnesium Hydroxide. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- (a) Preparations of the container: This includes, cutting. Stability Summary : (d). from the pre-exposure value indicates that the cause should be investigated. *Number of Registration and date of issue if plicable. 8. 26. Pharmacological and clinical data : 4.8 S.O.Ps for Testing 3. 7. 13. 6, Results of tests applied. (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; Register Your Self. (f) Any other tests. (b) children by age group. 7.3.1 Pre-Processing cleanliness checks The drug(s) or class(es) of drugs intended to be manufactured :- 3.3.1 General 13. General Room: 5. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. Duration: 2 years, annual system, NTS based examination Eligibility: (15) Labelling and packing benches, 4.9.6 Appropriate clothing and covering Mean initial temperature of each rabbit, 6. 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. The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. GOVERNMENT OF PAKISTAN Justification : (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. Equipment maintenance Procedure of Central Licensing Board: (1) The Central Licensing Board may, before issuing a licence, 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 Inspector 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 standarizing, if necessary, and analysing substances to be manufactured and enquire into the professional qualifications of the technical staff employed. 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. 4.9.1 Health examination The granulation, tableting and packing shall be done in this room. 10.1.8 Revision of specification (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. 6.4.2 Handling Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. Comparison of products shall be factual, fair and capable of substantiation. Ancillary Areas (ii) licence to manufacture by way of semi-basic manufacture; Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- (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. (2) Kettles, steam, gas or electrically heated. (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture; Japan, USA and European Company Member countries. 3. 3.3.5 Test Requirement for Finished Products 22. STEP 4: Apply for PSV. (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. 10.4.6 Finished product release procedure Sodium Sulphate. 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. (a) adequate space and equipment shall be provided; Monitoring of clean areas (iv) Validation Equilibrium with humidity and temperature A. 6 wherever necessary. Sterilization by ethylene oxide (e) Disintegration test (time in minutes). Serial Number. 63. of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions Building Design And Construction (General) 21. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. (3) Sifter or sieve. 4.8.4 Understanding concepts 5. DG Drug Module: A separate control panel has been developed for the DG Drugs Department for their due . 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