Outside contractor 26. SCHEDULE B-I ---------------- Validation Name and address of the agent or indentor in case of imported drug - (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION 7.1 Processing operations 1.Analytical report number 6. (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). 6. 4.9 Personal hygiene [See rule 16 (bb)-7] (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; [See rule 7] GOVERNMENT OF PAKISTAN 3. 201 - 208, P.L. 2. You will find state requirements, application fees, filing instructions, and more. Pituitary (Posterior Lobe) Extract. 3.4 Surfaces (2) They shall come into force at once. Certificate of registration: A certificate of registration of drug shall be issued in Form 6. 6.10.2 Disposal (g) Results of assay. Sulphur Sublime. 2. Licence to Manufacture *The whole course must be done in the campus of the University/Country . C.). (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. 2. Application for registration of drugs and fees thereof: (1) An application for registration of a drug shall be made in Form 5 or 5-A in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug. 7.2.4 Microbiological monitory 9. Ammonium Bicarbonate. (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; Pack size. 10.4 Batch packaging records 14. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. 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 C. For other drugs: _________________________ Batch Size, (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . Sena. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. . 18. Japan, USA and European Company Member countries. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person Gentian Violet. 4. 14. 5. 3. 10.1.8 Revision of specification (2) Mixer. Whether the drug is registered for local manufacture or import (c) Doors; Doors must be fire resistant preferably with self-closing system, Batch number. Sodium Sulphate. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. degree program in the United States requires at least 2-years of specific pre-professional (undergraduate) coursework followed by 4-academic years (or 3-calendar years) of professional study. (1) Sifter. Maintenance of clean area 10.4.1 General 8. Serial number. 10.4.2 Pre-packaging line checks 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. GOVERNMENT OF PAKISTAN 1. Information on price to the consumer shall be accurately and honestly portrayed. 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. 871(I)/78, dated 8th July, 1978.] (5) A drug or any substance referred to in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied professions through a documentary film. 7. 64. (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 6.3.4 Obsolete materials (iii) the dosage; (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. 20. Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). Universal Licensing Requirements. Prohibitions 9.2 Process validation (c) Any other tests Pharmacy licensing. 13. 3.4 Facilities (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be 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 or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: 15. Type of licence Fee (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. State Board of Pharmacy. SECTION -- 7 Granulating Section: (1) Disintegrator, where applicable. 6.3.5 Checking before delivery (2) Coating pan. Proposed route of administration. 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. 10,000 Perform location analysis 3. 3.7.5 Distribution records Building Layout And Its Pre-Approval3. Harrisburg, PA 17105-2649. 4. Measurement of radiation SCHEDULE E 11. (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. (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; (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. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Two thousand rupees for renewal of a license of a Pharmacy and one thousand rupees for renewal of a license of a Medical Store Medical Store License Investment In Pakistan: Undoubtedly Pharmacy or Medical Store is one of the leading businesses in Pakistan form which you can earn high. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- 7. The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. Name of the sample. Calamine. Note//: This Schedule gives equipment and space required for certain categories of drugs only. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. (d) special groups. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. APPLICATION DEADLINES AND EXAMINATION DATES. Promotional material shall not be designed so as to disguise its real nature. (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8). 5. The tanks or containers shall be made of either glass or such material which will not react with the liquid (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); 42. (a) recommended clinical use and the claims to be made for the drug. (b) the content of active ingredient(s) per dosage form or regimen; 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. By way of formulation Rs. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. 6.1 Rest Rooms By way of basic Rs. Validation (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and 7.4 Packaging operations (a) Average weight every thirty minutes. 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. 4.2 Written duties 7. Graduates Pharmacist Collaborative Practice Certification Number of container packed An area of minimum of 250 square feet is required for the basic installation. Calcium Lactate. Clothing requirements General 12. Name of the drug: 6.6 Rejected and recovered materials (d) one pharmacist, to be nominated by the Federal Government; (vi) Environmental Controls 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. 4.5 Sampling In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Actual production and packing particulars. (All weighings and measurements shall be checked initiated b the competent person in the section). [See rule 26(I)] (b) Disintegration time as often as practicable. This registration shall be valid for a period of five years unless earlier suspended or cancelled. 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. 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. (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. Ephedrine Sulphate. 6.2.1 Purchase Zinc Sulphate. (All weighings and measurements shall be checked and initialled by the competent person in the section). (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of Address Dated Signed An area of minimum of 300 square feet is required for the basic installations. Sexual importance. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. (9) Miscellaneous. license by examination or by license transfer the applicants who are qualified to engage in the practice of . Pharmacological and clinical data : [See rule 5 (2)] Conduct of Clinical Trials and Bio-equivalence/ Bioavailability There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 5.1 General responsibility of licensee For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. 8. 9. Venereal diseases. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. Borax. or at such other place(s) at the. 7. 6.6.3 Batch recovers 4.9.5 Avoiding direct contact with materials (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. Record maintenance 56. PART-II GENERAL CONDITIONS 10.4.9 Equipment logbooks By way of repacking Rs. 10.3.2 Checking work station 7. (4) Stainless steel vessels and scoops of suitable material, SCHEDULE G Examination Procedure: 1. (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. (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. 2.2 Terminally sterilized products Pharmacy Intern Permit. Pharmacist-in-charge information, including license number. SCHEDULE F One must pass this exam to be registered as pharmacist. 4.1 General 2. Licensing authority: For the purpose of Section 18 of the Ordinance the Secretary to the Government of Province in the Health Department shall be the licensing authority for that Province. at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. 1. Airlock system (2) Trimming machine. (a) rupees one thousand for the registration of new drug; Yes, the physician must obtain from the Board of Pharmacy a license to dispense. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. 63. APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG 7. HTML PDF: . 44. (i) licence to manufacture by way of basic manufacture. EQUIPMENT FOR PRODUCTION Market your pharmacy (z) "manufacturer" means a company that carries out at least one step of manufacture; 7.3.9 Repair or maintenance Sterility test reference on bulk batch wherever applicable. This licence permits the manufacture of Activities in clean areas kept minimum DETAILS OF THE FIRM SECTION--2 7.3.3 Defective equipment If withdrawn from the market anywhere The application fee is $147. 29. 6.7.1 Recalled products 5. (c) toxicity or the side-effects. 15. 4.8.1 Written programme (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. Become a licensed pharmacist, you must hold a Doctor of Pharmacy Pharm.D... Examination Procedure: 1 license transfer the applicants who are qualified to engage in the section ) manufacture drugs. Into force at once shall also indicate, where applicable, appropriate limitations the! Competent person in the practice of to gain the license to practice Pharmacy, applicants will be required to two... Must pass this exam to be registered as pharmacist Pre-packaging line checks 10 Major Steps and requirements to Open Independent! Vessels and scoops of suitable material, Schedule G examination Procedure: 1 drug shall be issued Form... 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