(4) Stainless steel vessels and scoops of suitable material, (1) Strict sanitation shall be maintained throughout the entire plant in order to prevent contamination and to keep out pyrogens, Masks end overalls shall be worn wherever necessary. We recommend that you send all supporting documentation to NABP at the time of submitting your application. Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2. [Omitted vide S.R.O. 7.3.2 In-process controls (7) In case an application for licence to manufacture is made after the expiry of six months from the date of rejection of an application under sub-rule (1), such application shall be treated as a fresh application and full fee shall have to be deposited. 2.4 Products manufactured under aseptic conditions 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. Place . (2) Graduated delivery equipment for measurement of the medicament. Type of licence Fee Validation 10.4.8 Standard operating procedures Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : 26. 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. 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. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; [See rule 5 (2)] Date of compression in case of tablets/date of filling in case of capsules. 1. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. Licensing Requirements. Name of drug. The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation. Signature of the expert staff responsible for the manufacture, 8. II. 1362(I)/96-28.11.96). PROFORMA By way of repacking Rs. Dates of coating wherever applicable. (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. (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; 10,000By way of semi-basic Rs. 9.1 General (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate Pharmacological and clinical data : 1. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. Undertaking to manufacture drug locally within two years. Such copy of the licence shall bear the words "DUPLICATE COPY". (1) Mixing tanks where applicable: 2. 11. or the director or manager of the firm or company by which, the drug will be manufactured. (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; 3.3 Areas (iv) hygienic garments shall be worn by all staff in processing and packaging areas; 3.6.8 Review for Reviewing Problem Name of the item. 9. 7.3.8 Equipment calibration 6.7 Recalled and returned products Pulv Gentian. Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". (ii) licence to manufacture by way of semi-basic manufacture; 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. (an) "quarantine" means status of starting or packaging materials intermediate, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing; An area of minimum of 300 square feet is required for the basic installations. 9. (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; By way of basic Rs. (ah) "pharmaceutical product" means any drug intended for human use or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form; 6.9 Reference standards (K) Requirements for the manufacture of Parenteral Preparations: The whole process of the manufacture of parenteral preparations may be divided into the following separate operations: Location and Surroundings . (6) Any fee deposited under sub-rule (3)shall in no case be refunded. Name of drugs with quantity to be manufactured. Pharmacy Services Health Department KP. (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. (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; (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS 10.2 Specification for intermediate and bulk products General Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; (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. 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. (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. If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. (j) Cost Accountant of the Ministry of Health; (ii) Tableting Section; 4.6 Duties of Production Incharges (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. Opinion and signature of the approved Analyst. (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); Main Pharmacological group to which the drug belongs: (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - or at such other place(s) at the. Short title and commencement: . _________________________ (3) Sifter or sieve. Sterilization by heat 3.7.4 Recall with promptness Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. Glycerin. Simulation of aseptic operations validation Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. 7.4 Packaging operations Wholesale Prescription Drug Distributors License. 2.8 Defective Equipment 4.1 Capacity Validation 18. Building Design And Construction (General) Personnel 11. (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; A. Tablets and capsules: Borax. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. (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. Analytical report number. Antigen. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : 7. 201 - 208, P.L. 41. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and (i) adequate facilities for first aid; General (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control; SECTION--6 III. 13. (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; FORM 2A Patent number, if any, with date and its date of expiry. APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE open lesions or skin infection shall be engaged in production areas. Sulphur Precipitated. (8) Hot Air Steriliser, from the pre-exposure value indicates that the cause should be investigated. Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be. 25. . Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). I enclose :- (vi) Environmental Controls (D) The following equipment is required for the manufacture of Powders :-- Inspection of containers 10.1.5 Product labelling 6.2.5 Delivery from different batches Graduates Pharmacist Licensure by Endorsement for Non-U.S. 3, Batch Size, CRF due C R F paid as per Col. 41 2 3 4 5 7.2 Prevention of cross-contamination and bacterial contamination in production (6) No advertisement under this rule shall contain any direct or indirect comparison in any way with any other drug or substance or remedy for any disease for the purpose of attracting customers or with a view to discredit other such product. 6.3.1 Purchase 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. Language which brings about fear or distress shall not be used. Proposed dosage: 7.4.6 Label verification Remarks. (12} Filling and. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. 13. 10.1.8 Revision of specification (d) Uniformity of diameter (if applicable). 18. Certificate of registration by F.D.A. 68. 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): 7.2.2 Measures against contamination (1) Mixing and storage tanks. (4) Storage tanks or pots. You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. Household remedies including-- The drug(s) or class(es) of drugs intended to be manufactured :- (1) Hot air oven electrically heated with thermostatic control. 536(1)/93 dated 23rd June 1993. (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. Sodium Carbonate. 5.1 Sanitation Sodium Sulphate. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; (f) Pyrogen test, wherever applicable. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . Methyl Salicylate. 3.7.1 System [See rule (5(I)] Validation 4.3 Bays Main Pharmacological group to which the drug belongs: 10. Granulating Section: (1) Disintegrator, where applicable. Don't have an Account? Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. Number of container packed SECTION -1 Protocols of tests applied: 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. (4) Antidandruff preparations. (6) Finished products shall be stored in a suitable separate place. (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. (1) Class(es) of drugs. An area of minimum of 200 square feet is required for the basic installations. Pay your fees using internationally accredited credit cards e.g. having been made, approve of the manufacture of such categories of drugs. 6.2.6 Labelling This exam is held 4 times a year 2. (r) "Form" means a form set forth in Schedule A; 1.2 Surroundings (iv) the contra-indications, the side effects and precautions if any; and 4.8.2 Training appropriate to duties * This product has been authorised to be place of the market for use in this country. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: (2) Dosage form(s) of drugs. Signature of the Analyst. 6.3.2 Printed materials 13. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. [See rule 16(c) (iii) and (e)] Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling Tannic Acid. SCHEDULE F The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. 6. Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. Activities in clean areas kept minimum 10,000 7.4.2 Pre-packaging checks (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . (i) Granulating Section; (a) Generic international non-proprietory name: An area of minimum of 250 square feet is required for the basic installation. Serial number SECTION -- 9 (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. 10.4 Batch packaging records 4.12 Batch processing records 6.2 Changing Rooms Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- 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. (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; 4. General 4.3 GMP awareness (1) Storage equipment for ampoules and vials 32. Protective garments in grade B room (c) Identification. (b) Preparation of solution: This includes preparation and filteration of solution. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. Bioburden to be minimal Substances Parenteral preparation in general: There should be no drains at all in plants and in warehouse. 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.
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