QUALITY CONTROL DEPARTMENT SECTION--2 3.3.4 Test requirement for in-process controls (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. Liquid Paraffin Heavy. 10.4.3 Recording packaging operation 9. The tanks or containers shall be made of either glass or such material which will not react with the liquid (a) The generic name(s) of the active ingredient(s); 4. GENERAL CONDITIONS 6.10.2 Disposal 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. 7. 3. (f) Pyrogen test, wherever applicable. Use of disinfectants and detergents Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. By way of basic Rs. 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: The text shall be fully legible. Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. Warranty under Section 23(I)(i) of the Drugs Act, 1976 17. An area of minimum of 200 square feet is required for the basic installations. FORM 6 9, Opinion and signature of the approved Analyst Pyrogen Tests:- (iii) licence to manufacture by way of formulation; Sufficient time allowed to reach required temperature 3.7.4 Recall with promptness (1) Mixing and pouring equipment. 3.4.2 Items for self inspection 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; Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . 2. (a) adequate space and equipment shall be provided; SCHEDULE D 30. 6.11 Miscellaneous Sera. Name of the sample Soft yellow Paraffin. (d) any directions for. VALUE (in Rs.) LICENCE TO MANUFACTURE DRUG(S) 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. The bachelor's (B.S.) Records of the disposal of rejected batch and batches with-drawn from the market. 22. 9.2.1 Validation of critical processes In order to avoid over-promotion, the main part of the volume of sales they generate. The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule. 12. 250 or by fax at 518-402-5354.; The State Education Department is not responsible for any fees paid to an outside testing or credentials verification agency. FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. [See rule 7] GOVERNMENT OF PAKISTAN 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. Sodium Potassium Tartrate. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. PH of the solution wherever applicable. (3) An application under sub-rule (1) shall be accompanied by fee or-- 17, Actual production and packing particulars indicating the size and quantity of finished packings, 60. Individuals who withdraw their licensure application may be entitled to a partial refund. 4. 2. 27. 4.9 Weighing Area 4.4 Prohibition of unauthorized person Place.. Name, designation and address (a) Average weight every thirty minutes. 1. 6. III. (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. [See rule 31 (1A) and (1B)] Dosage from of the drug: 7.3 Processing operations intermediate and bulk products SCHEDULE A 6.2.9 Correct dispensing 3.4.1 General Validation Mean initial temperature of each rabbit, Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. 10.1.8 Revision of specification Sterilization by dry heat Date of Registration Secretary Registration Board (Seal) Chairman. 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. Renewal of a licence: On application being made for renewal, the Central Licensing Board may cause an inspection to be made, and if satisfied that the conditions of the licence and the rules are and will continue to be observed, shall issue a certificate of renewal or otherwise reject the application and inform the licencee accordingly. FORM 1-A Omitted vide S.R.O. (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 Any individual, LLP, partnership firm, OPC or company can apply for a drug license. 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. Calcium Carbonate. (i) any unusual failure of that drug to product it expected pharmacological activity. washing, drying sterilisation of ampoules or vials prior to The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. 17. (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; Batch Size, (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. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). SECTION-I Total. 4. 9.2.3 Validation of equipment if materials The contract Date of release finished packings for distribution or sale. 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. Sodium Thiosulphate. (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 58. pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. 28. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. Register Lost your Password? 2.3 Construction Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. 7. Dated (Signed) Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS SECTION -1 Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. 1. 1. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. (e) The Quality Control Department shall be independent of the manufacturing units and its incharge shall be a whole-time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry, or a degree in medicine, microbiology, pharmacology, or bacteriology from a university in Pakistan or any other institution recognised by the Federal Government for the purposes of Ordinance, as the Central Licensing Board may deem fit for any particular unit; and shall be independent of the incharge of the manufacture (Production Units). Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- (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; Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : 3.7.2 Authorized procedures (5) Mixing tanks for processing medicated dressings. 9. 8. Once approved, the agency will schedule a site inspection. 22. General (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. Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and (g) The applicant shall provide-- (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; 4.1 General 10.4.8 Standard operating procedures (4) Water still. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Powder, powder, powder, powder, powder mixture for capsule products e.g.! Withdraw their Licensure application may be entitled to a partial refund lacomotive pharmacy license requirements in pakistan multiple... 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