We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. (d) Sterilisation. 8. Sufficient water must be available for fire-fighting. Pharmacy (In-State Only) License. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- 6.2.8 Released materials to be used (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-- 2.4 Products manufactured under aseptic conditions 3. Pharmacy Services Health Department KP. Name of the sample. 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. 10.4.6 Finished product release procedure Sanitation and hygiene Sterilization by radiation [See rule (31)1] 3.4 Surfaces American Boards of Pharmacy Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 16. (2). Analgesics: 4.3 Specifications for Starting and Packaging Materials (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: Boric Acid. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- Fax - (717) 787-7769. 5. 10.1 Documents FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). REQUIREMENTS OF PLANT AND EQUIPMENT Name of the sample. Value of raw materials used (Active & inactive) (in Rs.) Changes, if any, in information furnished at the time of initial registration or last renewal _________________________ There should be no drains at all in plants and in warehouse. (3} Granular 21. Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container. 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. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. Salicylic Acid. If drains are absolutely necessary they must not contract directly with waterways or public sewers, 4. SECTION--2 11. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; [See rule 2 (e)] Contract Giver Serial Number. 10. 58. (e) Disintegration test (time in minutes). Gripe Waters. Records of readings taken to check weight variation in case of capsules, 7. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. 7.1.1 General 6.9.1 Testing prepared reference standard 5,000 Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. SECTION-2 (b) the content of active ingredient(s) per dosage form or regimen; Precautions against contamination 10. 11. 6, Date of injection, Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. 4.9 Personal hygiene Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Equipment maintenance The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). (as) "reprocessing" means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operations; Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. (B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :-- 10.4.7 Recording batch distribution (6) Antacid and carminatives: SCHEDULE B I-A. Castor Oil. Licence to Manufacture Name of the material 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 This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: Name and address of the agent or indentor in case of imported drug - 34. 48. (c) toxicity or the side-effects. (a) for adults. 5 whenever necessary. An area of minimum of 200 square feet is required for the basic installations. (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters, (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; Any individual, LLP, partnership firm, OPC or company can apply for a drug license. (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and A written contract between the contract giver and the contract acceptor shall clearly establish the duties of each party had state the way in which the authorized person shall exercise his full responsibility in releasing each batch of product for sale or issuing the certificate of analysis and a copy of such a contract shall be supplied to the Central Licensing Board also. 66. Signature of the examiner. Nebraska Governor Pete Ricketts recently signed Executive Order No. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : (iii) the dosage; 3.2 Services If package inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this Schedule. 2. (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. (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of Handling procedures 3. 3.4 Self inspection (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. 6. An area of minimum of 300 square feet is required for basic packing operations. ----------------------- 14. 6.6.3 Batch recovers (f) side-effects and major adverse drug reactions; (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. 65. 10.1.3 Documentation system For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. 10.4.3 Recording packaging operation 7.4.3 Labeling packaging line SANITATION AND HYGIENE 5. Register Lost your Password? Licensing Authority. Duration of the exam is 2 hours 3. 6. (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. General (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. (d) Omitted by S.R.O. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. Temperature of each rabbit noted at suitable intervals, In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. Methyl Salicylate. Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. Name and address of the manufacturer: Area of minimum of 200 square feet is required for the basic installation. (ii) Details of the premises including layout plan of the factory. or at such other place(s) at the. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 6.5.1 Quarantine (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; PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS SECTION -- 7 13. Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. 11. 7.2 Prevention of cross-contamination and bacterial contamination in production (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. 7.3.4 Cleaning containers Magnesium Hydroxide. 3, Batch number Apply for insurance 11. Care against fibers 18. 5. CHAPTER I - PRELIMINARY Resorcin. Date of Establishment. _________________________ (2) Granulator. (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; Comparison of products shall be factual, fair and capable of substantiation. (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). (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ . Sterility test reference on bulk batch wherever applicable. (4) Oven thermostatically controlled. 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. Have a desire to help 2. 4.2 Written duties 12. [See rule (5(I)] Pharmacy Technician Registration Requirements & Application (online application) Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible. 7.3.5 Yield deviations Number of mice used and weight of each mouse, Strength and volume of the drug injected, (iii) licence to manufacture by way of formulation; 4.9 S.O.Ps for Sanitation 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. PREMISES Filtration of pharmaceutical products that cannot be sterilized in the final container (1) Storage equipment for ampoules and vials Certificate of registration: A certificate of registration of drug shall be issued in Form 6. Central Licensing Board may from time to time permit. 10.1.8 Revision of specification 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. 4.9.7 Foods and drinks prohibited Sterilized non-sterilizer products differentiation [See rule 21(3)] (3) Drier. 67. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 7.3.8 Equipment calibration SCHEDULE D FORM 2 Initial investment (and details of equity shares). (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. 6.3.2 Printed materials Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. (8) Autoclave. Individuals who withdraw their licensure application may be entitled to a partial refund. Name(s) of the drug(s): Protocols of tests applied: approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: 6.1.1 Quarantine Present investment (and details of equity shares). (iii) Name of the approved expert staff. Calcium Gluconate. (i) Granulating Section; (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; [See rule 17(1)] Sulphur Sublime. Year 7.3.9 Repair or maintenance The application fee is $147. 4.8 Training Place.. Name, designation and address 14. (1) Disintegrator, where applicable. Reference to Analytical Report number stating whether of standard quality or otherwise. Signature of the Analyst. How to get a pharmacy license in Pakistan? MANUFACTURE BY WAY OF FORMULATION Collaborate with a contractor 6. (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. ACPE Graduate - Original License: Applicants for a pharmacist license must be at least 18 years of age; and hold a baccalaureate or doctorate degree in pharmacy from a school or college or pharmacy accredited by the Accreditation Council for Pharmacy Education. 31. Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. The License can be renewed as it is valid for up to five years. Air Classification system for manufacture of sterile products . (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. 22. 39. Number of containers filled. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. 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. (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. (b) PH wherever applicable, (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; By way of basic Rs. 2. Omitted vide S.R.O. or the director or manager of the firm or company by which, the drug will be manufactured. (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. (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 A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . 12. Borax. Magnesium Trisilicate. 4.5 Duties of Heads of Departments 3. (ak) "purity" means the degree to which other chemical or biological entities are present in any substance; Building Design And Construction (General) (c) infants. Monitoring each cycle For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. PART-II (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; Control reference numbers in respect of raw materials used in formulation. (2) Trimming machine. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. 5 wherever necessary. (g) The applicant shall provide-- Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case. 2. (2) Analgesic Balms/Plasters. GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO 6.11 Miscellaneous 15. Once approved, the agency will schedule a site inspection. *The whole course must be done in the campus of the University/Country . 16. (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. 3.4.4 Frequency of self inspection By way of repacking Rs. Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Serial number 4.2 Specification & Testing Procedures (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. 7.1.2 Material handling (e) any error in the labelling of that drug; There have been/have not been any change in respect of May include compounding Non-Resident 4.9 Weighing Area 8. 10.1.9 Packaging material specification (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. GOVERNMENT OF PAKISTAN 7. 24. Sterilization 10.4.10 Equipment utilization record Sodium Carbonate. C. 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