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. 1. (c) The manufacture shall be conducted under the 'active directions and personal supervisions of competent technical staff conisting of at least one person who is a whole-time employee and who has-- 4. In Pakistan a person who has following qualification will be considered as an eligible candidate for course of pharmacy technician; Matriculation with science from a recognized institute of Pakistan. General Total. 3 Name under which drug is proposed to be sold (b) Preparation of solution: This includes preparation and filteration of solution. *Number of Registration and date of issue if plicable. Iodine. (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. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- Resorcin. (2) Graduated delivery equipment for measurement of the medicament. (c) Doors; Doors must be fire resistant preferably with self-closing system, : 3.4 Self inspection (iv) the contra-indications, the side effects and precautions if any; and 28. 6.11 Miscellaneous Validation 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! Order cabinetry 7. 5000By way of semi-basic Rs. Conditions or registration of drug: (1) The relevant provisions of the Ordinance and the rules in respect of the registered drug, shall be complied with. Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. Ingredients : Boric Acid. 10,000 (c) For pyrogens wherever applicable. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; Date of commencement of manufacture and date of completion. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. RECORDS OF RAW MATERIALS Proposed route of administration: (c) "authorized person" means a person responsible for the release of batches of product for sale; SECTION--5 3. Pharmacological group _________________________ 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products. (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. 19. 4. Dated (Signed) 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. Sulphur Precipitated. 6, Date of injection, (6) Finished products shall be stored in a suitable separate place. 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, All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments. 3. 9.2.2 Validation of new master formula [See rule (5(I)] Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. 6.3 Packaging materials Name of the material PART-I (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. Comparison of products shall be factual, fair and capable of substantiation. HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Sterilization General (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; Vaccines. (d) name of manufacturer or distributor. (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. Results of assay. 18. Sulphur Sublime. (a) The factory premises shall comply with the conditions specified in Schedule B. 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: 6.10 Waste materials 3.3.2 Sampling Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; Bacteriophages. The Central Licensing Board shall, in respect of such categories of drugs, have the discretion to examine the adequacy or otherwise of factory premises, space, plant, machinery and other requirements having regard to the nature and extent of the manufacture to carry out necessary modifications in them and, on the modification. (ar) "retail sale" means a sale other than wholesale; 11. Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; 5. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). Stability Summary : Super Easy Way to Start Pharmacy Business in Pakistan! 8. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). 5,000 Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning Contract production and analysis This licence permits the manufacture of (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. Asepsis of articles in clean areas (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; 3. Ferrous Sulphate. SECTION-I 1. (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; I enclose :- 9. 6.7.1 Recalled products Monitoring of clean areas Name of the sample. Gentian Violet. 9. Ancillary Areas Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number 277 (1)/96 dated 2 lst April 1996. Serial number 39. having been made, approve of the manufacture of such categories of drugs. 57. (e) dosage form or regimen; 7.4.4 Process continuity 7.2.2 Measures against contamination (7) Liquid filling equipment. MATERIALS 44. The following basic hygienic requirement shall be complied with 4.3 Bays Name of drug. Date of filling. The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. 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 :-- (f) side-effects and major adverse drug reactions; The word "safe" shall not be used with respect to promotion unless properly qualified. 1. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: SCHEDULE G 1.1 Location Have a desire to help 2. 14. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 3. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' 46. [See rule 16 (6) (b)] Batch number. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. The following equipment required :- 18. 19. 3. Validation 7. 17. (d) special groups. (2) Power Mixer or granulation mixer with stainless steel cabinet 4.5 Duties of Heads of Departments Dated Signed (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool (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); 29. (ii) Reasons thereof. (d) special groups, SCHEDULE B-I (i) ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use are as required by the marketing authorization or product specification; and 16. 5. 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 4.4 Quarantine 17. (c) major precautions, contra-indications and warnings, if any; and Sodium Bicarbonate. (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. 15. A. (See rules 19 and 30) Analytical report number. Potassium Chloride. (2) Stainless steel scoops end vessels. SECTION-1 7.3.7 Water pipes 12,500 6.9.1 Testing prepared reference standard Sodium Citrate. 56. 6.5.1 Quarantine 1. 14. 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions 10.4.5 Analytical records (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. (j) Cost Accountant of the Ministry of Health; [See rule 16(c) (iii) and (e)] 3. 551(1)//93, dated 3. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. 4. (a) Preparations of the container: This includes, cutting. By way of basic Rs. (5) Mixing and storage tanks of stainless steel or of other suitable material. Procedure 20. 4.8.3 Specific training 12. 5.2 Dedicated Facilities for Production Name of the manufacturer/supplier. 10.1 Documents Ammonium Carbonate. (a) recommended clinical use and the claim to be made for the drug. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate Sufficient water must be available for fire-fighting. (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. Cough Preparations. Procaine Hydro-Chloride. 6. Contract Giver Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. 4.9 S.O.Ps for Sanitation 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. Omitted vide S.R.O. CRF due C R F paid as per Col. 41 2 3 4 5 Quality control (c) infant 7.1.6 Labelling The License can be renewed as it is valid for up to five years. 1. 8. [See rule 17(1)] 1. Validation 3.7.9 All concerned to be informed 3.5.1 Audit by independent specialist 16, Records on the disposal of rejected batches and batches with-drawn from the market. 43. (B) For the renewal of Registration 2. (a) the name under which the drug may be sold; (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. 68. Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. (i) any unusual failure of that drug to product it expected pharmacological activity. 4.6 Packaging Instructions (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 Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. Name, address and status of the applicant: (b) Disintegration time as often as practicable. 48. 12. Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. Calcium Lactate. Promotional material shall not be designed so as to disguise its real nature. 9. Care against fibers In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) (13) No drug manufactured under licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. 4. By way of formulation Rs. 3.2 Basic requirements Sodium Iodide. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). (6) Filtering equipments such as filter press or sintered glass funnel. 3.7.3 Written procedures 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. 38. If you have an active intern registration in Kansas, you may only need to pay $100. (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. 6.2.6 Labelling Manufacturing Area : Potassium Bicarb. (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; 3.1 Quality Control Department Pharmacy Services Health Department KP. 11. SCHEDULE B 8. 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; (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; Name(s) of Proprietor(s)/Director(s)/Partner(s). 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 :-- 10.4.9 Equipment logbooks 27. (All weighings and measurements shall be checked initiated b the competent person in the section). SCHEDULE F (6) Sintered glass funnel, seitz filter or filter candle. By way of basic Rs. Weight of each rabbit. (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. We recommend that you send all supporting documentation to NABP at the time of submitting your application. Pharmacological and clinical data : 4. (16) Storage equipment including cold storage and refrigerators, if necessary (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; Name of drug, under which it is proposed to be sod: 10.1.10 Starting material re-assay 67. ST-PHARMACY@PA.GOV. 1 2 3 (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. (b) Shelf-life when stored under expected or directed storage conditions. [See rules 28 and 29(4)] Ammonium Bicarbonate. open lesions or skin infection shall be engaged in production areas. 6. Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. (iv) Validation Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. Maximum temperature. Gripe Waters. (14-A) The contributions made towards the Central 'Research Fund under sub-rule (14) shall be kept in such bank as the Federal Government may specify and shall be utilised in accordance with the Drugs (Research) Rules, 1978. Including particulars of time temperature and pressure employed Super Easy Way to Start Pharmacy Business in Pakistan See 16... Batch number of a recognized Assistant pharmacist certificate Sufficient Water must be available for fire-fighting with area! Prepared reference standard Sodium Citrate to be made for the North American pharmacist Examination... 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