25. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Name of drug, under which it is proposed to be sod: 1. 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. Monitoring water supply of sources Filling and Sealing Room: If you want to do your own job as a pharmacist in the state of Maharashtra, then you . 30. (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; (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. 13. 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. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. 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. Use of protective garments Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. 8. The following equipment is required in each of the three sections :- 6.3 Packaging materials (ii) the route of administration; II. 46. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. Sodium Sulphate. (6) Finished products shall be stored in a suitable separate place. Storage Areas (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; Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. 5. [See rule 31 (10)] 6. 20. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978: (4) Storage tanks or pots. 5. Name of the sample. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. (ii) Cost of each packing material. Pharm.D. FORM -5(A) Methyl Salicylate. 10.4.2 Pre-packaging line checks By way of repacking Rs. (4) Antidandruff preparations. Year Summed response, 8. 3.5 Quality Audit 7.3.2 In-process controls 22. Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- Each state may have different individual . 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization. (e) Testing, 1.Analytical report number 2. Sodium Carbonate. SECTION-1 2. Sufficient time allowed to reach required temperature (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions: 6. Sterilized surgical lignature and sterilized surgical suture. Sulphur Sublime. 2. Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. 2.2 Terminally sterilized products 14. 15. The invitation letter should accurately reflect the presentations and discussions to be held. and detailed records must be kept. (9) Benches for filling and sealing. Name of the Sample Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. FORM 4 (b) Identification. 1. 6.2.1 Purchase Calamine. 17. 6.2.9 Correct dispensing (1) Mixing equipment. 4.5 Sampling If you have an active intern registration in Kansas, you may only need to pay $100. Cough Preparations. washing, drying sterilisation of ampoules or vials prior to Dated (Signed) 5. Batch number. GOOD PRACTICES IN MANUFACTURING PROCESSING Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. By way of basic Rs. SECTION -- 4 (c) the statement of all the representations to be made for the promotion of the drug in respect of-- 4.7 Duties of Quality Control Incharges Precautions during cooling (e) Disintegration test (time in minutes). (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. Sulphonilamide Powder (B. VET. 18. Manufacturing Area : 1. (ar) "retail sale" means a sale other than wholesale; (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences. 1362(I)/96-28.11.96). 7. (i) the claims to be made for the drug; (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. An area of minimum of 300 square feet is required for the basic installations. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 2. E. Container, packing material, etc. Prohibitions HTML PDF: . (5) Mixing tanks for processing medicated dressings. (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. Pack size. 6 wherever necessary. 7.2 Prevention of cross-contamination and bacterial contamination in production Eliminate fibers [See rule 16 (6) (b)] 4.9.7 Foods and drinks prohibited There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 7. sealing unit, A minimum of 17 hours of CE earned in any combination of the following pharmacy-related subject matter: Medication or drug distribution; Inventory control systems; Mathematics and calculations; Biology; Pharmaceutical sciences; Therapeutic issues; Pharmacy operations; (i) If the application for renewal if made before the expiry of period of validity of licence. 14. 4.7 Standard Operating Procedures (SOPs) and Records (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- Personnel training 5. (i) Class(es) of drugs. (ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : Boric Acid. (c) major precautions, contra-indications and warnings, if any; and 12. 7.4.9 Product re-introduction on packaging line 1. Opinion and signature of the approved Analyst. Date of compression in case of tablets/date of filling in case of capsules. Pharmacy Services Health Department KP. 7. (d). 3.2 Basic requirements (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. Signed (iv) licence to manufacture by way of repacking; and 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 (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. 7. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; (5) Various liquid measures and weighing scale. Test Report number. 4. 7.4.4 Process continuity (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. 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. Description of bill of sale, invoice, bill of lading or other document (if any). (a) Description. 4.9 Personal hygiene There have been/have not been any change in respect of 7.2.2 Measures against contamination 15. Date of issue .. Sign in to start your session. By way of formulation Rs. Quality control Name(s) of the drug(s): SECTION--5 of tablets, injections tubes litres etc. (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). 7.3 Processing operations intermediate and bulk products (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; Opinion and signature of the approved Analyst. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. 2. 3.6 Complaints Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; FORM 5 (c) Uniformity of weight. 8. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. 4, Date of receipt of sample 10. 2. 4.8.3 Specific training (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. (z) "manufacturer" means a company that carries out at least one step of manufacture; Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. 551(1)//93, dated 3. Initial investment (and details of equity shares). 53. Control reference numbers in respect of raw materials used in formulation. 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