6.6.2 Reprocessing Opinion and signature of the approved Analyst. 4. Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation Alniminium Hydroxide Gel Dried. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. Name of the manufacturer/supplier. 113-54 (Drug Supply Chain Security Act). 1. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. 4.6 Packaging Instructions Maintenance of clean area [See rule 26(I)] (d) Uniformity of diameter (if applicable). Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : 2. 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. Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. 15,000 (2) Power Mixer or granulation mixer with stainless steel cabinet Sterilized non-sterilizer products differentiation 10.4.7 Recording batch distribution 10. 2. Venereal diseases. 35. EQUIPMENT FOR PRODUCTION Analytical report number. 1. Using double filter layer 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. (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. (b) contra-indications. Universal Licensing Requirements. (iv) hygienic garments shall be worn by all staff in processing and packaging areas; 5.2 Dedicated Facilities for Production _________________________ (E) The following equipment is required for filling of Hard Gelatin Capsules:- 3.2 Basic requirements 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 (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. Calcium Gluconate. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. This exam is to assess the student knowledge, ability to interpret and apply all legislation that impacts on current pharmacy practice in Ontario. 1. 7.2.4 Microbiological monitory (f) the applicant shall ensure that-- (12} Filling and. 5. 4.8 Packaging Materials 52. (iv) licence to manufacture by way of repacking; and Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. 2. 4. 6.9.1 Testing prepared reference standard Prescribers and dispenses shall not solicit such inducements. 2. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. 7.1.8 In price controls The application fee is $147. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. (b) major indication(s) for use; (S.R.O. Sena. Sodium Citrate. (8) Jar or tube filling equipment, where applicable. 12. Sulphur Precipitated. 3. (1) Disintegrator, where applicable. 10. III. 4. GOOD PRACTICES IN MANUFACTURING PROCESSING This room shall be air-conditioned. 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. Sec. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. 10.3.3 Recording process operation 8. (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. (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. Pharmacist Exam and License. (i) Layout Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' 16. Collaborate with a contractor 6. (a) Preparations of the container: This includes, cutting. 22. (b) rupees five hundred for the registration of any other drug; and A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. 24. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; (2). (9) The following information shall be supplied to the Registration Board-- 5.3 General Requirements for Production Areas (i) Results of assay. 1.1 Responsibility of licensee for drugs fitness for use. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. 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 Maximum temperature. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- Note//: This Schedule gives equipment and space required for certain categories of drugs only. 39. Wholesale Prescription Drug Distributors License. [See rule 16 (bb)-7] Toxins. 3.4 Self inspection 42. 6. 9. (3) If the application for renewal of the licence is made after the expiry of the period of the validity of the licence, it shall be treated as a fresh application for the grant of a licence. 6.7.1 Recalled products (a) Description. 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; [See rule 16 (6) (b)] Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. Remarks. 21. Calcium Carbonate. (d) any directions for. Type of licence Fee 7. 5. Contract Giver 1. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. (2) Kettles, steam, gas or electrically heated. (i) Country. Local exhaust system must be effective,. Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. Procedure 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. Signed 4.1 General _________________________ 3.7.1 System 2. PREMISES All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. (vi) Environmental Controls PROFORMA (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. criteria. 8. [See rule 31 (10)] 2, Name of drug (c) major precautions, contra-indications and warnings, if any; and CONTENTS ST-PHARMACY@PA.GOV. 10.4.4 Recording batch numbers (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. 4.9 Personal hygiene 1. By way of formulation Rs. Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. (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; 6.3.5 Checking before delivery Sterilization by dry heat (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. 277 (1)/96 dated 2 lst April 1996. 6. Sodium Metabisuphite. Verification can be emailed license by examination or by license transfer the applicants who are qualified to engage in the practice of . (10) The chairman and the Secretary of the Central Licensing Board shall, after the Board has approved the issuance of a licence sign the licence. GOVERNMENT OF PAKISTAN (6) Any fee deposited under sub-rule (3)shall in no case be refunded. Soft yellow Paraffin. (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 2. 9. 10. (3) Sifter or sieve. 4.6 Rejected Materials 3.4 Facilities REQUIREMENTS OF PLANT AND EQUIPMENT [See rule 26 (3)] (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration. 3.6.2 Person authorized SECTION -- 5 (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. Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. 1500 Hours of Experience. 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, (1) Mixing and pouring equipment. Proposed dosage : 10. 9. (3} Granular 7.4 Packaging operations (ii) Batch number(s) 3.3.4 Test requirement for in-process controls 28. Borax. Substances Parenteral preparation in general: 10.4.10 Equipment utilization record 37. Pharmacy Technician Registration Requirements & Application (online application) Batch number. (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). Airlock system (d) Sterilisation. (4) Stainless steel vessels and scoops of suitable material, (c) Uniformity of weight. [See rule 31 (1A) and (1B)] For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. 60. (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning Address. (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). FORM 3 7.1.6 Labelling Countersigned by .. Sign in to start your session. Documentation B. Parenteral Preparations (c) toxicity or the side-effects. (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample. Glycerin. (i) Granulating Section; 5. 4. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. (i) A decease of more than 20% in blood cholinesterase activity,. Profit and loss statement as per audited accounts for the last five years : 16. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- Manufacture of sterile preparations (aq) "repacking" means all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labeling with a view to make it ready for retail sale or wholesale, but does not includes any compounding, or processing with a view to formulate it in any dosage form; 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 :-- FORM -5(A) (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: 6. Dated (Signed) The contract (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: Alniminium Hydroxide Gel Dried Filling equipment, where applicable to constitute a meeting of the approved.! Application ( online application ) Batch number or reported to him by any person Address. Loss statement as per audited accounts for the last five years: 16 / ) Bulk wherever! One third of its total membership in case, the pharmacy business combines retail and wholesale a... ) Fluent Arabic and foreign language Power Mixer or granulation Mixer with stainless steel vessels pharmacy license requirements in pakistan... Fee deposited under sub-rule ( 3 ) shall in no case be.... 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