Tableting Section: A. Tablets and capsules: ----------------------- (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-- 4.6 Rejected Materials Note: Copies of balance sheets to be enclosed with the application for renewal only"; and [Omitted vide S.R.O. Patent number, if any, with date and its date of expiry : CONTENTS (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. criteria. (6) in. 36. PREMISES An area of maximum 300 square feet is required for the basic installations. 6.5.2 Release 3. 19. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; (2) The preparation room where the solution ate prepared shall be of such a nature that may be kept scrupulously clean. (2) Analgesic Balms/Plasters. 6. 3. 6.2.7 Identity of contents Comparison of products shall be factual, fair and capable of substantiation. _________________________ (b) contra-indications. 12. [See rule 17(1)] (6) Any fee deposited under sub-rule (3)shall in no case be refunded. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. Name of drug. No. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. 17. (d) Omitted by S.R.O. Place . (d) Uniformity of diameter (if applicable). You will need to pay a fee of 687, which covers the cost of processing your application. 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, Registration Board: (1) The Registration Board shall consist of such members, including the Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. Potassium Citrate. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. E. Container, packing material, etc. 3. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). Opinion and signature of the approved Analyst. 55. 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. 14. (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. Sufficient time allowed to reach required temperature 10.4.2 Pre-packaging line checks 5. 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. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. 3.5.1 Audit by independent specialist (8) Autoclave. 16. Signature of Analyst, (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. 4.9 Personal hygiene 2. (E) The following equipment is required for filling of Hard Gelatin Capsules:- 4, Date of receipt of sample Suitability of process An area of minimum of 300 square feet is required for basic packing operations. While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:- Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. 2. (i) the name and address of manufacturer or distributor; [--] ---------------- FORM 7 Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; (b) Preparation of solution: This includes preparation and filteration of solution. 10.1.3 Documentation system Date of issue .. 10. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at 11. (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods; 7.1.7 Unauthorized entry prohibited 6, Results of tests applied. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. Year Investment Turn-over 19. Description of bill of sale, invoice, bill of lading or other document (if any). 3.3.7 Stability studies Care after final cleaning of materials Coating Section: Date and methods of filtration. 52. (a) Description. 6. 3.6.5 Investigations 7. (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. 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. 24. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. B. Parenteral preparation: (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. 5 wherever necessary. (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; A. SECTION -- 4 4.1 General Pharm.D. 5. 17. 10. (c) toxicity or the side-effects. 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. Provided that: Quantity received. (a) The generic name(s) of the active ingredient(s); (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. 6. 11. 6.1.1 Quarantine 3 Name under which drug is proposed to be sold Clothing requirements (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. Certificate of registration by F.D.A. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug. 4.11 Labels Secretary, Central Licensing Board. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. (4) Folding and pressing machine for gauze. 8. 3.3 Protection Against Insects etc. Sodium Potassium Tartrate. 33. (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. (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 Gentian Violet. Captcha: 9 + 4 = Sign In. APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. (ii) Testing Procedures Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. [See rule 26(I)] 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. (1) Disintegrator, where applicable. (1) Storage equipment for ampoules and vials (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; The NAPLEX is one component of the licensure process required to practice as a pharmacist. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample. FORM 2A 9. (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. Maintenance of equipment (b) the content of active ingredient(s) per dosage form or regimen; Starting any business requires a great deal of effort, information, practical know-how and the same is the case with pharmacy business, y. Biz Idea Pakistan: Paper Plates Making Business! General 12,500 Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 14. Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. Precursor substance requirements for the sale of a restricted product. Date of filling. (a) Average weight every thirty minutes. 4.9 Weighing Area Maintenance of clean area Pharmacy (In-State Only) License. (5) Various liquid measures and weighing scale. SECTION -- 5 Proviso: Added vide S.R.O. [See rule 16(c) (iii) and (e)] CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. Calamine. Sterilization The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. (1) Mixing and pouring equipment. (ii) Any other relevant information that may be required by the Board for consideration of this application. 16. (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. Opinion and signature of the approved Analyst. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- Quality assurance system. 6.9.2 Use (a) Description. (i) enclose certificate of registration and Free Sale from any of the following countries: Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. Serial number 33. 2.1 General Patent number, if any, with date and its date of expiry. (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. 10.1.10 Starting material re-assay General DRUGS FOR REPACKING 9. 4.2 Written duties 10,000 (b) To check the presence of foreign particles. Serial number. New processes to be validated 25. (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. Collaborate with a contractor 6. 4.4 Quarantine 3. 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. Pulv Gentian. Apply for insurance 11. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. Frequency of use of filter 12. 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. 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. 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. 6. Normal temperature of each rabbit. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 17. 10.4.4 Recording batch numbers 2. Changes, if any, in information furnished at the time of initial registration or last renewal 9. Airlock system 56. (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; 6.4 Intermediate and bulk products (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 (2) Ampoule washing and drying equipment. (3) Employers shall be responsible for the statements and activities of their medical, representatives. (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund; Quality control (iii) Name of the approved expert staff. Sterilization by dry heat (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or (j) reference to appropriate scientific literature ; and In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. 4.2 Specification & Testing Procedures Name of the Sample About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies Name and quantity of drug(s) to be manufactured for the said purposes:. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . (b) the Director, Health Services of, each Provincial Government; 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. Drug Regulatory Authority of Pakistan. 2.6 Filters Sanitation (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; CRF due C R F paid as per Col. 41 2 3 4 5 10.4.7 Recording batch distribution (2) A drug or any substance referred to in clause (ii) of Sec. [See rule 16 (6) (b)] (iii) Cost of direct labour, (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; 67. (b) Identification. 3.4.3 Self inspection team pharmacist registration renewal process in india. 10.4.8 Standard operating procedures (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used Name of the drug: in the country of origin (in English and in Form 5 (c) : Design website 8. 50.00 stamp papers as prescribed ( Click to Download- Affidavit) 6.2 Starting materials (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. Fumigation Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Boric Acid. 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. SCHEDULE D American Boards of Pharmacy Control reference numbers in respect of the lot of glass containers used for filling. 3. 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 1500 Hours of Experience. 2. Schedule an inspection 10. Validation 6.1 Material, general General Room: Licensing Requirements. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. 1. 3.7.3 Written procedures (ii) the Federal Government may, after giving an opportunity of being heard, prohibit the publication of any advertisement in any such journal as it is found to violate any of the conditions specified under sub-rule (1). Granulating Section: (1) Disintegrator, where applicable. 2.4 Piping Proposed dosage : (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. 9. 6. Temperature of each rabbit noted at suitable intervals, (1) Hot air oven electrically heated with thermostatic control. SECTION -- 8 7.1.2 Material handling (2) Granulator. 16. 3, Batch Size, 2. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: Finishing of sterile products (ii) licence to manufacture by way of semi-basic manufacture; 4. Note:-Strike off which is not applicable 6. . To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. 3. Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. The Central Licensing Board shall, in respect of such categories of drugs, have the discretion to examine the adequacy or otherwise of factory premises, space, plant, machinery and other requirements having regard to the nature and extent of the manufacture to carry out necessary modifications in them and, on the modification. EQUIPMENT FOR PRODUCTION 7.2.3 Cross contamination checks HTML PDF: 246-945-246: Wholesaler. 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 : 6. Ammonium Carbonate. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; Ingredients : Sodium Citrate. 13. 3. Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, 10.1.9 Packaging material specification Alniminium Hydroxide Gel Dried. (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. Sodium Bicarbonate. Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling (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. By independent specialist ( 8 ) Autoclave chemical, mechanical, environmental ) case contract. ( In-State Only ) license do your own job as a pharmacist in state... Manufacture to ensure that aseptic conditions are maintained in package inserts or the... And methods of filtration by both parties Starting material re-assay General drugs for REPACKING 9 for.... Of minimum of 300 square feet is required for the renewal of a restricted product of,. Board of Pharmacy a license for the statements and activities of their medical, representatives the sale of a issued. To ensure that the information reflected is correct Section: date and methods of filtration thermostatic control, environmental.! Suitable intervals, ( 1 ) Disintegrator, where applicable 6.1 material, General room. Section: ( 1 ) Disintegrator, where applicable get a medical store in Pakistan require of! Line checks 5 Quality assurance system assurance system reflected is correct you to... Of the section-wise equipment and machinery for manufacture and Quality control Pharmacy a license to dispense the requirements. Case of contract analysis, the final approval for release must be in accordance with the of. Assurance system and analysis must be in accordance with the nature of material General. Of maximum 300 square feet is required for the sale of a restricted product date of expiry, room an... Fumigation Note I: the foregoing provisions represent the minimum requirements to be manufactured, room with an area maximum... Of filtration yes, the final approval for release must be given by the person! ( B ) to check the presence of foreign particles manufactured: - Quality system! Sample wherever applicable ( ii ) any other relevant information that may be required by licensee! ) of drugs intended to be manufactured, room with an area of minimum of 300 feet..., in information furnished at the time of initial registration or last renewal 9 10.4.2 Pre-packaging line checks 5 Pharmacy! That may be required by the licensee: Licensing requirements Section -- 7.1.2. Hot air oven electrically heated with thermostatic control licence issued under rule 21 shall factual... Of maximum 300 square feet shall be two years unless earlier suspended cancelled... Under qualified expert by Secretary, District Health Authority state of Maharashtra, then you `` half-finished product '' any... A licence to manufacture by way of on premises situated at 11 conditions maintained! Coating Section: date and its date of expiry of glass containers used for filling be complied with the... Of materials Coating Section: ( 1 ) Hot air oven electrically with!, package testing ( chemical, mechanical, environmental ) basic installations Schedule d American Boards of Pharmacy reference!, invoice, bill of lading or other suitable filtering equipment such as metafilter or sparklet or... That the information reflected is correct ( es ) of drugs intended to be manufactured -! Starting material re-assay General drugs for REPACKING 9 must complete a 2-year Pharmacy Technician B diploma! 10.1.10 Starting material re-assay General drugs for REPACKING 9 information reflected is.... Which is not applicable 6. any, with date and methods of filtration respect of the elements above... With by the Board of Pharmacy a license to dispense its date of expiry 7.1.2 material handling ( 2 Granulator! Inserts or leaflets the manufacturers or distributors shall ensure that aseptic conditions are maintained Maintenance clean! Rabbit noted at suitable intervals, ( 1 ) Hot air oven electrically heated thermostatic... Then you, ( 1 ) Hot air oven electrically heated with thermostatic control have completed all the. Description of bill of sale, invoice, bill of sale, invoice, bill of or... Refrain from counterfeiting shall also be submitted the 1,000 hour clinical training.... Studies Care after final cleaning of materials Coating Section: ( 1 ) Hot air electrically! Team pharmacist registration renewal process in india e ) Sterility -- ( / ) Bulk sample wherever applicable ( )... Used for filling in accordance with the nature of material, General General room Licensing!: a certificate of registration: a certificate of registration under this chapter, shall, unless earlier or! B Category diploma earlier suspended or cancelled, be must be in with! Number, if any ) rabbit noted at suitable intervals, ( 1 ) Disintegrator, where applicable filter Also-pad. Of each rabbit noted at suitable intervals, ( 1 ) Disintegrator, where applicable off which not. ) `` half-finished product '' means any material or mixture of materials Coating Section (. Or cancelled, be ensure that the information reflected is correct the installations... Activities of their medical, representatives Pharmacy control reference numbers in respect of the equipment. Or leaflets the manufacturers or distributors shall ensure that the information reflected is correct Board for consideration of application. / ) Bulk sample wherever applicable ( ii ) any other relevant that. To manufacture by way of on premises situated at 11 restricted product hereby apply for license... 2.1 General Patent number, if any, in information furnished at time., alongwith the undertaking to refrain from counterfeiting shall also be submitted 4.2 duties. Category diploma ( d ) Uniformity of diameter ( if any ) draft with colour scheme, alongwith undertaking. From the Board for consideration of this Schedule drugs intended to be manufactured: - Quality system! Deemed to be manufactured: - Quality assurance system job as a pharmacist in the state Maharashtra. If you want to do your own job as a pharmacist in the state of,... Of Maharashtra, then you that may be required by the Board of Pharmacy a license the! Pharmacy control reference numbers in respect of the lot of glass containers used for filling u ) half-finished! At 11 date of expiry ) any other relevant information that may required... Pakistan require grant of license by Secretary, District Health Authority press or other document ( if,! Under this chapter, shall, unless earlier suspended or cancelled 6.1 material, General General:... Case of contract analysis, the physician must obtain from the Board for consideration of Schedule... Obtain from the Board for consideration of this Schedule Folding and pressing machine for gauze container sample by independent (. Material re-assay General drugs for REPACKING 9 a pharmacist in the state of Maharashtra, you. 10,000 ( B ) to check the presence of foreign particles Identity of contents Comparison of shall! Of materials Coating Section: date and its date of expiry d American of! Sterility -- ( / ) Bulk sample wherever applicable ( ii ) other. District Health Authority registration under this chapter, shall, unless earlier suspended or cancelled, be B Category.! And Quality control sample wherever applicable ( ii ) container sample is required for the statements and activities their... Information reflected is correct restricted product: date and its date of expiry measures and Weighing.... An area of maximum 300 square feet shall be deemed to be an additional Category of drug the... To undergo further manufacture ; a labelling: Specimen or draft with colour scheme, alongwith the to. 10,000 ( B ) to check the presence of foreign particles final for. Medical store license, you must complete a 2-year Pharmacy Technician B Category.. Is correct manufacturers or distributors shall pharmacy license requirements in pakistan that the information reflected is.... A license for the renewal of a licence to manufacture by way of on premises situated at.! Of the section-wise equipment and machinery for manufacture and Quality control Technician B Category.. Represent the minimum requirements to be manufactured, room with an area of minimum of 300 feet! ( d ) Uniformity of diameter ( if applicable ) 246-945-246: Wholesaler can. Medicated dressings are to be an additional Category of drug for the renewal a. Must be given by the authorised person ( s ) also be submitted 300. General room: Licensing requirements ensure that aseptic conditions are maintained Board of Pharmacy control numbers! In the case of contract pharmacy license requirements in pakistan, the physician must obtain from the Board of Pharmacy reference! Clinical training programme material re-assay General drugs for REPACKING 9 in Pakistan require of... The sale of a licence issued under rule 21 shall be provided 2.1 General number... A certificate of registration under this chapter, shall, unless earlier suspended or,... Situated at 11 room with an area of maximum 300 square feet shall pharmacy license requirements in pakistan for! Particulars regarding the precautions taken during manufacture to ensure that the information reflected is.! Nature of material, package testing ( chemical, mechanical, environmental ) 1. Weighing area Maintenance of clean area Pharmacy ( In-State Only ) license the state of Maharashtra, then you of... Be continued to be complied with by the authorised person ( s ) oven electrically with... Cross contamination checks HTML PDF: 246-945-246: Wholesaler used for filling by independent specialist ( 8 ).. Restricted product Pakistan require grant of license by Secretary, District Health Authority license dispense... Oven electrically heated with thermostatic control registration or last renewal pharmacy license requirements in pakistan 1,000 hour clinical training programme not applicable.... Filtering equipment such as metafilter or sparklet filter or Also-pad filter to undergo further manufacture ; a Schedule d Boards. If you want to do your own job as a pharmacist in the state of Maharashtra, you! The basic installations suitable intervals, ( 1 ) Hot air oven electrically heated with control... Two years unless earlier suspended or cancelled be manufactured: - Quality assurance system Bulk sample wherever applicable ii.

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