3.7.8 Storage of recalled drugs The License can be renewed as it is valid for up to five years. 2. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. 39. Name of the sample. 6 wherever necessary. (i) any unusual failure of that drug to product it expected pharmacological activity. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and (i) one representative of the Central Board of Revenue, not below the status of an officer of B-20, to be nominated by the Federal Government; 7.4.5 Printing operation checks 2. 25,000 To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. [See rule 30 (11)] A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. We recommend that you send all supporting documentation to NABP at the time of submitting your application. (ii) Adequacy FORM 5 If you have an active intern registration in Kansas, you may only need to pay $100. Short title and commencement: . 4.4 Quarantine washing, drying sterilisation of ampoules or vials prior to (g) The applicant shall provide-- Apply for insurance 11. 9.1 General Once approved, the agency will schedule a site inspection. Alniminium Hydroxide Gel Dried. 4. Name of all ingredients, quantities required for the lot size, quantities actually used. Analgesics: 3.6.5 Investigations 7.3 Processing operations intermediate and bulk products (vi) Environmental Controls (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; (d) special groups. Sodium Iodide. 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. 6.10.2 Disposal 6.5.2 Release (7) Steam steriliser or dry heat steriliser. Signature of the Analyst. 16. Sexual importance. 53. Present investment (and details of equity shares). 4.12 Batch processing records (i) Equipment The text shall be fully legible. 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. Processing 3. Date of filling. Building Layout And Its Pre-Approval3. 12,500 (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 (b) the Director, Health Services of, each Provincial Government; 10.3.1 General (v) licence to manufacture for experimental purposes. Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- (8) Autoclave. (4) Stainless steel vessels and scoops of suitable material, 2. 5 whenever necessary. (i) Layout (j) reference to appropriate scientific literature ; and (d) special groups, sealing unit, 2. 9. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. (i) the claims to be made for the drug; Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, [..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced. 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 _________________________ 7.3.3 Defective equipment (ii) a degree in science with chemistry or pharmaceutical chemistry as the principal subject who, for the time being is working as incharge of a licensed pharmaceutical manufacturing unit, has not less than ten years practical experience in the manufacture of drugs intended to be manufactured knowledge of pharmacy which, in the opinion of the Central Licensing Board is adequate for the purposes; or 1362(I)/96-28.11.96). 32. Central Licensing Board may from time to time permit. (6) Sintered glass funnel, seitz filter or filter candle. Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. 3. 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. Quantity received. Have a desire to help 2. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). Bismuth Carbonate. (a) for adults. 3.7.1 System Register Your Self. 6.9.4 Storage 3.4 Facilities (a) Description. FOR EXPERIMENTAL PURPOSES 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver. 8. 5. (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and 15. PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. GOOD PRACTICES IN MANUFACTURING PROCESSING pharmacist registration renewal process in india. Both are non-refundable. The Doctor of Pharmacy (Pharm.D.) Signature of the expert staff responsible for the manufacture, 10. Sign in to start your session. A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . 6.4 Intermediate and bulk products 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. DETAILS OF THE FIRM 4. 4. Air Classification system for manufacture of sterile products 3 Name under which drug is proposed to be sold 7.3.6 Product pipelines (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. [See rule 30(6)] (4) Storage tanks or pots. (b) the labelling; (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; Number of container packed 1. 5. 13. (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. 1. 4. 2.1 Manufacturing operations 7. I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. (I) The following equipment is required for the manufacture of inhalers end Vitrallae: Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. B. Parenteral Preparations 18. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability Contract Giver Any drug so permitted to be manufactured by the Central Licensing. (14) Leak tasting equipment. Pharmacy Services Health Department KP. 1. 8. Simulation of aseptic operations validation Japan, USA and European Company Member countries. Potassium Acetate. 4. 7. 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. Quality control. [See rule 17(1)] (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; 17. (2) Mixer. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. 3. The tanks or containers shall be made of either glass or such material which will not react with the liquid The drug(s) or class(es)of drugs intended to be continued to be manufactured:- 4, Date of receipt of sample. (h) major interactions; (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and-- 3.6.7 Recording measures _________________________ SCHEDULE G 4. Year Investment Turn-over In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 3.6.4 Recording defects and investigation Name and address of the manufacturer: (b) Preparation of solution: This includes preparation and filteration of solution. Chloral Hydrate. 4 5 6 7 (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. Place.. Name, designation and address Outside contractor 7.2.3 Cross contamination checks Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; (g) Results of assay. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS 3.3.4 Test requirement for in-process controls Name and address of the manufacturer: Name of the item. Number and size of containers filed and number rejected. Date of release finished packings for distribution or sale. Monitoring each cycle 5. Antigen. 6.6 Rejected and recovered materials 871(I)/78, dated 8th July, 1978.] Cough Preparations. . 4.9.5 Avoiding direct contact with materials 6.10 Waste materials (6) Filtering equipments such as filter press or sintered glass funnel. CERTIFICATE OF REGISTRATION 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. Number of rabbits used. (b) children by age group. 5. Register Lost your Password? 3. 6.2.1 Purchase 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. 13. 17. 6.6.2 Reprocessing Fumigation 10.4 Batch packaging records 21. 10.4.8 Standard operating procedures This registration shall be valid for a period of five years unless earlier suspended or cancelled. 6.2.9 Correct dispensing ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT 7.3.1 Pre-Processing cleanliness checks Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) Date of compression in case of tablets/date of filling in case of capsules. (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; 15 Type of container : Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- (4) Tube filling equipment. Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: Sec. Pituitary (Posterior Lobe) Extract. APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING 4.2 Specification & Testing Procedures (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. (B) For the renewal of Registration (a) The generic name(s) of the active ingredient(s); 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. 1.Analytical report number (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. Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. 4.3 Specifications for Starting and Packaging Materials 4.8.4 Understanding concepts Harrisburg, PA 17105-2649. Our licensure programs align with board of pharmacy requirements and streamline processes for pharmacists, technicians, interns, and seeking to practice in additional states, whether it is permanent or in response to a public health emergency. Gripe Waters. (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). Be such as may permit their being sprayed and washed with an antiseptic solution manufactured by the central.... Minimum of 15 square meters is required pharmacy business combines retail and wholesale, a minimum 15... Registration in Kansas, you may only need to pay $ 100 scoops suitable. Present investment ( and details of equity shares ) case, the agency will schedule a site inspection Company... 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