3.7.7 Evaluation Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- Sulphur Precipitated. 42. Programme participants are normally referred to as 'pharmacy interns'. Antigen. 4.5 Duties of Heads of Departments While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. 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; Signature of the expert staff responsible for the manufacture, 4, Date of receipt of sample Alniminium Hydroxide Gel Dried. (c) toxicity or the side-effects. Precautions against contamination (b) major indication(s) for use; (S.R.O. Form-5 (Click to Download) 2) Fill an affidavit on Rs. Sign in to start your session. (9) Benches for filling and sealing. Collaborate with a contractor 6. Methyl Salicylate. 4.6 Packaging Instructions (iii) Surfaces Sufficient time allowed to reach required temperature PREMISES 3. 5.1 General responsibility of licensee 3.1 Quality Control Department 2. Ensure contact between gas and microbial cells 10.1.2 Recording actions The wording of the pcakge inserts or leaflets, if prepared specially for patients, shall be in lay language subject to the condition that the medical and scientific content is properly reflected. Signature of the Analyst. 4. 3. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; 40. For Foreign-trained Pharmacy Graduates / Pharmacists. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. Protocols of tests applied. Date and methods of filtration. Stability studies : 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. SECTION -- 3 FORM 4 Air supply system (6) A triple-roller mill or an ointment mill, where applicable. FORM 6 ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG 7. 7.2.2 Measures against contamination Serial Number. FORM 5 190.00 Renewal Fee. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 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. 4.12 Batch processing records 24. Present investment (and details of equity shares). FORM-5B (7) Liquid filling equipment. 7.4.8 On-line packaging checks (r) "Form" means a form set forth in Schedule A; (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. (3) Sifter or sieve. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. 10. (b) children by age group. Coating Section: 21. 10.4.5 Analytical records Potassium Acetate. in Pharmacy. Provided that: (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. (e) Testing, 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 PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS 7.4.1 Avoiding mix-ups [See rule 5 (/)] (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. Location and Surroundings . SECTION--3 (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. 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. 1. It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. 3. Name of the drug. Name and address of the manufacturer: 17. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. Interval between operations to be minimal General SCHEDULE B-II 6. Magnesium Hydroxide. Certificate regarding sale and G.M.P. (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; 3.5.2 Suppliers audits (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; (e) dosage form or regimen; "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- 53. Name, address and status of the applicant: Calcium Carbonate. 10. Value of raw materials used (Active & inactive) (in Rs.) (7) Autoclave, (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate E. Container, packing material, etc. (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form; ST-PHARMACY@PA.GOV. (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. 31. Name of drug, under which it is proposed to be sod: (v) Drains 6.6.3 Batch recovers Quality assurance system. Vaccines. 4.9 Weighing Area Records of tests employed :-- 11. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. (i) Layout 7.2 Prevention of cross-contamination and bacterial contamination in production (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. (ii) Where the usual information on indications and dosage is provided, that advertisement material shall contain information on contra-indications, side effects and other necessary precautions as may be applicable. SCHEDULE G 2. 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. 14. 6.6.1 Storage and disposal HTML PDF: 246-945-246: Wholesaler. (c) Identification. Signature of the Analyst, Verification of Licensure - If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure will be required to be submitted directly to this office by the licensing agency of any state of the United States in which you hold or ever held a license. (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. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). 1. (d) special groups, Undertaking to manufacture drug locally within two years. 7.3.8 Equipment calibration (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. 9. If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. 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. I enclose :- 18. 5.2 Hygiene how to apply dha exam for pharmacist. Sufficient water must be available for fire-fighting. Secretary, Central Licensing Board. 22. 4.9.6 Appropriate clothing and covering (5) Mixing and preparation tanks or other containers. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. (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. 6.3 Workshops 54. (6) in. Castor Oil. 25. 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. (iv) Services Sodium Thiosulphate. 18. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. (d). Pharmacy Technician Registration Requirements & Application (online application) This room shall be air-conditioned. Filter safety 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. of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. 13. PH of the solution wherever applicable. Schedule an inspection 10. (10) Filling and sealing unit SECTION -- 5 6.10 Waste materials 6.5.2 Release Sodium Bicarbonate. 6 wherever necessary. Any drug so permitted to be manufactured by the Central Licensing. 7.1.4 Yield checks (3) Weighing and measuring equipment. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. 3. 5,000 Patent number, if any, with date and its date of expiry. Sodium Benzoate. Personnel training 3. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 17. Registration Board Duration: 2 years, annual system, NTS based examination Eligibility: Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : Year Procedure 34. Pulv Gentian. (1) Sifter. 4.5 Master Formula . Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). (11) Subject to rule 14, the Central Licensing Board may appoint a licensing authority or authorities for such purpose as it may deem fit. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration; (b) Disintegration time as often as practicable. 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! (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. 3. Name of the Sample 6.9.1 Testing prepared reference standard Batch number. sub-rule (8); and 3.4 Self inspection 6.9.2 Use American Boards of Pharmacy Tannic Acid. Quality control 2.8 Defective Equipment Name of the drug, (d) special groups. Kaolin. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; (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 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. Potassium Iodine. (k) Price of the drug, ; and Protective garments in grade B room 13. (E) The following equipment is required for filling of Hard Gelatin Capsules:- (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; 1. Name and quantity of drug(s) to be manufactured for the said purposes:. 5.2 Dedicated Facilities for Production 63. Sodium Carbonate. SCHEDULE G Simulation of aseptic operations validation CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, Note:-Strike off which is not applicable 15 Type of container : Name of all ingredients, quantities required for the lot size, quantities actually used. A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . (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: 08.80.040 . (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. Wholesale Prescription Drug Distributors License. Resorcin. B. Parenteral preparation: 1. (1) Mixer. 2.1 Manufacturing operations 10.3.1 General Weight of granules. (2) A drug or any substance referred to in clause (ii) of Sec. Bacteriophages. Dosage from of the drug: Toxicity Test: 6.2.10 Checking wherever necessary (4) Oven thermostatically controlled. Quantity received. STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE 6. Safety instructions should be strategically displayed in local language. (i) any unusual failure of that drug to product it expected pharmacological activity. SECTION--2 (5) The meetings of the Central Licensing Board may be held at such time as the Board may deem fit and, on the request of any of its members, the Chairman may at any time call a meeting if there is any important matter for its consideration. Potassium Bromide. 33. Ferrous Sulphate. APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. An area of minimum of 250 square feet is required for the basic installation. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. 33. 12. Stability Summary : 6.2.6 Labelling Building Design And Construction (General) (a) Generic/international non-proprietary name: 6.1 Material, general 20. 4. 5. 4. Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. Opinion and signature of the approved Analyst. General Room: (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; 4.8.1 Written programme 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. CRF due C R F paid as per Col. 41 2 3 4 5 Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level. 3 Name under which drug is proposed to be sold (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals 3. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- Address A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. 15. 3.5 Quality Audit SECTION -- 7 2. 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. 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