Records of tests employed :-- Inspection of containers The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. 8. Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. Batch number. (a) For the grant of licence: Name of the sample 13. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. (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. Cough Preparations. Use of disinfectants and detergents PART-II 15. 6.1 Rest Rooms (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. Boric Acid. 17. P.O. Pennsylvania Licensure Requirements. III. (2) The licence shall be kept on the licenced premises and shall be produced at the request of any member of the Central Licensing Board or of Provincial Quality Control Board or an Inspector. 5.1 Sanitation Invoice/Challan number and date. (ii) Testing Procedures Caffein and its Salts. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; 6. (d) special groups, Serial Number. SECTION--3 (6) Antacid and carminatives: APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. 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. (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - (ii) Others Normal temperature of each rabbit. Phenothlazine (B. VET. Sign in to start your session. (vi) Environmental Controls (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); 3.1 Quality Control Department If drains are absolutely necessary they must not contract directly with waterways or public sewers, Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Test Report number. 8. 8. 24. 5. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. Solution of serum proteins intended for injunction. (6) in. (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. or at such other place(s) at the. 3.4.1 General (iii) Written Procedures 4.9 S.O.Ps for Sanitation Recording sterilization cycle After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. Ingredients : For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, [See rule 16 (bb)-7] Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. (4) Antidandruff preparations. Provided that in the case of drugs specified in Schedule C, the Central Licensing Board may allow the applicant to make arrangements with some other institution approved by the Central Licensing Board for such tests to be regularly carried out on his behalf by that institution. Initial investment (and details of equity shares). Main Pharmacological group to which the drug belongs: Name of the manufacturer/supplier. and detailed records must be kept. (2) Coating pan. Air supply system The more commonly issued license is the "practitioners of the healing . (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: (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. HTML PDF: 246-945-246: Wholesaler. Short title and commencement: . If withdrawn from the market anywhere I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. The room shall be air-conditioned and also dehumidified wherever necessary. [Omitted vide S.R.O. 6.5.1 Quarantine 3.4.6 Follow-up Action (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; 4. (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. Ammonium Chloride. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Vaccines. (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be. ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT Phone - (717) 783-7156. (a) Generic international non-proprietory name: (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. 10.1.8 Revision of specification 3.7.9 All concerned to be informed Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. 2. 10. (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. 19. ------------------------ 22-04 to avoid a healthcare workforce shortage emergency. Care for biological indicators Potassium Iodine. ----------------------- Among the list of the best college for b category in Thokar Lahore Campus: 0301-6979333 | Hujra Shah Muqeem Okara Campus: 0304-6979333 | Ellahabad Kasur Campus: 0305-6979333 | alquaidcollege@gmail.com General Local exhaust system must be effective,. Benzoic Acid. 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. (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. 277 (1)/96 dated 2 lst April 1996. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and 18. 3.4.2 Items for self inspection (f) Any other tests. 3. 35. 32. _________________________ Type of licence Fee The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; Quality control. CERTIFICATE OF REGISTRATION 3.2 Basic requirements open lesions or skin infection shall be engaged in production areas. 4. (1) Mixing and storage tanks. (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time; (5) Pessary and tablet counter. 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- 2. 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. (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). (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. Sale at more than one place .- (1) If a person desires to sell, store, exhibit for sa le or distribute drugs at more than one place, he shall apply for a separate license in Using double filter layer Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | boardofpharmacy@wv.gov The BPS Board Certified Pharmacotherapy Specialist (BCPS) program is a credential for pharmacists who have met the eligibility criteria below and who in their unique practice ensure the safe, appropriate, and economical use of medications as part of interprofessional treatment teams in a variety of settings, including hospitals and health systems. 9. (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; 3.7 Product recalls 2. (k) One physician, to be nominated by the Federal Government; 4.4 Specifications for Finished Products SECTION -- 5 5. (c) toxicity or the side-effects. 10. (d) Omitted by S.R.O. DOCUMENTATION (c) Any other tests 7.1.6 Labelling (1) Rolling machine. Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, (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: 45. 2. Sodium Bicarbonate. Monitoring each cycle Form-5 (Click to Download) 2) Fill an affidavit on Rs. (b) children by age group. ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG For Foreign-trained Pharmacy Graduates / Pharmacists. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. 7.3.9 Repair or maintenance 5. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. (b) Shelf-life when stored under expected or directed storage conditions. 17. 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. 2.3 Construction Provided that: DRUG REGISTRATION FEE About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies Sterilization by heat 4. 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