Equipment maintenance 11. SECTION--5 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. (a) recommended clinical use and the claim to be made for the drug. Date of granulation wherever applicable. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. (2) The preparation room where the solution ate prepared shall be of such a nature that may be kept scrupulously clean. SECTION--3 (d) Volume in container, 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. 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. 68. 15. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- 12. 3. 1.1 Location 4. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. (ii) Adequacy (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool 6.1.2 Appropriate storage 17. 4.3 Specifications for Starting and Packaging Materials SCHEDULE A SCHEDULE B-I 2.2 Layout SECTION--2 2. An area of minimum of 200 square feet is required for the basic installations. Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. 35. REQUIREMENTS OF PLANT AND EQUIPMENT Design website 8. [See rule 26(3A)] They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. Sodium Potassium Tartrate. If it is not possible, the reasons therefor. The NAPLEX is one component of the licensure process required to practice as a pharmacist. Handling procedures (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. Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board. Name of the sample. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. III. Tableting Section: (c) Any other tests Serial number (2) Kettle, gas or electrically heated with suitable mixing arrangement. (c) Uniformity of weight. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. 19. 1. 2.7 Cleaning Equipment (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. 10,000 (9) The following information shall be supplied to the Registration Board-- Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (ar) "retail sale" means a sale other than wholesale; (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; 10.3.3 Recording process operation 4. 31. (14-A) The contributions made towards the Central 'Research Fund under sub-rule (14) shall be kept in such bank as the Federal Government may specify and shall be utilised in accordance with the Drugs (Research) Rules, 1978. 16. Name of drugs with quantity to be manufactured. 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 (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. (4) Water still. 6. 7.1.2 Material handling pharmacist registration renewal process in india. 7.2.1 Precautions against dust 14. In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- Methylene Blue. (2) Mixer. 4. 1. Pharmacy Intern Permit. Pharmacological and clinical data : (7) Liquid filling equipment. 6.6 Rejected and recovered materials As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. 6.4.1 Storage Proposed shelf life with storage conditions, if any : 3.6.7 Recording measures (1) Disintegrator, where applicable. 20. Captcha: 9 + 4 = Sign In. 6.10.2 Disposal from the pre-exposure value indicates that the cause should be investigated. 7. Cetrimide Powder. Zinc Sulphate. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. Name of the drug, [See rule 30 (11)] 3.6.5 Investigations Certificate of registration: A certificate of registration of drug shall be issued in Form 6. Borax. 7. Name of the sample An area of minimum of 200 square feet is required for the basic installations. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: (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. 21. 1. 10.4.4 Recording batch numbers (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. (b) the labelling; (c) toxicity or the side-effects. ----------------------- 20. 10,000By way of semi-basic Rs. 7.1.6 Labelling 6.9.3 Working standards Name of the sample. Ephedrine Hadrochloride. Contract acceptor approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: 12,500 Each of our licensure programs fulfils different pharmacists' needs. PRACTICE OF PHARMACY AS A PROFESSION. 17. Simulation of aseptic operations validation 1. Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) 3, Batch Size, 6.2.1 Purchase DETAILS OF THE FIRM (i) any unusual failure of that drug to product it expected pharmacological activity. Graduates Pharmacist Licensure by Endorsement for Non-U.S. Activities in clean areas kept minimum 48. of Pack Total quantity in terms of individual units e.g., total No. 2. Iodine. Vaccines. 64. (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and (8) Autoclave. (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; (2) Capsule filling units. Equilibrium with humidity and temperature (g) The applicant shall provide-- (2) Power Mixer or granulation mixer with stainless steel cabinet 4.7 Special Materials 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. (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; DRUGS FOR REPACKING 1.1 Responsibility of licensee for drugs fitness for use. 27. (v) Storage Care against fibers (d) one pharmacist, to be nominated by the Federal Government; 2. (Seal) Chairman, Central Licensing Board. (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; (ii) Batch number(s) (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. General Protocols of tests applied. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. SECTION -- 8 One must pass this exam to be registered as pharmacist. (g) Results of assay. (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; 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). 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. (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. Stability studies : 7.4.11 Destruction of un-used packaging materials (d). By way of basic Rs. 8. The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. (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; Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person (12} Filling and. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. 1. Statement of the Central Research Fund. 1. 1. Quantity received. (a) Description. 25. Pharmacist-in-charge information, including license number. washing, drying sterilisation of ampoules or vials prior to II. Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. Precautions during cooling (2) Coating pan. In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; In order to avoid over-promotion, the main part of the volume of sales they generate. Maintenance of equipment (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; 4.1 Capacity (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. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 10. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and 6.4.2 Handling 20. or the director or manager of the firm or company by which, the drug will be manufactured. Stability Summary : Quality control [See rule 26(I)] 5 wherever necessary. (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. (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 3.3 Areas Signature of the Analyst. (iii) Name of the approved expert staff. (9) Miscellaneous. Caffein and its Salts. 8. (4) Stainless steel vessels and scoops of suitable material, 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. Antitoxins. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. Calcium Lactate. Pulv Gentian. 2.3 The contract giver shall ensure that all processed products and materials delivered by the contract acceptor to comply with their specifications or that the product has been released by the authorised person(s). Monitoring each cycle MATERIALS Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. [See rule 20 (b)] (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; open lesions or skin infection shall be engaged in production areas. Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. Form 1 SECTION-2 APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE WHICH IS PROHIBITED Antigen. 4.4 Prohibition of unauthorized person 6.1 Material, general Entry restricted The drug(s) or class(es) of drugs intended to be manufactured :- 1993. Sentonin. 10. 2. (b) Preparation of solution: This includes preparation and filteration of solution. A. Tablets and capsules: The bachelor's (B.S.) (b) Proprietory name, if any: 4. (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning (d) any directions for. 7.3.2 In-process controls 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. how to apply dha exam for pharmacist. 4. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. (c) major precautions, contra-indications and warnings, if any; and 6.11 Miscellaneous (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of Collaborate with a contractor 6. 44. Sodium Bromide. Filling and Sealing Room: Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. 22. FORM -5(A) (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. 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. 3. ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT 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. 871(I)/78, dated 8th July, 1978.] Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- (2). 7. . 5.1 General Facilities (1) Class(es) of drugs. Register Lost your Password? Sampling of drugs: Samples of drugs may be provided to the physicians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words "Physicians Sample Not for Sale". (c) "authorized person" means a person responsible for the release of batches of product for sale; (4) Folding and pressing machine for gauze. sealing unit, There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. Storage Areas 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. 8. B. Parenteral preparation: (4) Antidandruff preparations. 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. Degree or. (3) An application under sub-rule (1) shall be accompanied by fee or-- (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). Sterilization Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. Sterilized non-sterilizer products differentiation The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. Pack size. 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. 3, Batch number 15 Type of container : 10.1 Documents SCHEDULE G 9. 28. (1) Hot air oven electrically heated with thermostatic control. By way of repacking Rs. (g) any failure of one or more distributed batches of that drug to meet the required specifications; [See rule 31 (1A) and (1B)] FORM-5B 8. (8) Hot Air Steriliser, 18. (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. 6.2.7 Identity of contents Forms of licenses to sell drugs .- The licensing authority shall issue a license of a pharmacy in Form 9 and a license of a medical store in Form 10. Gentian Violet. 7.2 Prevention of cross-contamination and bacterial contamination in production (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; Manufacture of sterile preparations (d) Sterilisation. Each state may have different individual . Changes, if any, in information furnished at the time of initial registration or last renewal 60. 4.12 Batch processing records 9. 3.3.6 Production record/batch review (2) Ampoule washing and drying equipment. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 5. (iv) Services Note: Copies of balance sheets to be enclosed with the application for renewal only"; and 6.10.1 Storage 3. (3) Drier. (11) Subject to rule 14, the Central Licensing Board may appoint a licensing authority or authorities for such purpose as it may deem fit. 6.5.2 Release The License can be renewed as it is valid for up to five years. Date of commencement of manufacture and date of completion. Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf. 4.8.2 Training appropriate to duties Records of readings taken to check weight variation in case of capsules, 1. (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; The word "safe" shall not be used with respect to promotion unless properly qualified. degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). (b) contra-indications. Monitoring water supply of sources The granulation, tableting and packing shall be done in this room. 8. Provided that: 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. Validation 4.3 Bays Bioburden to be minimal 3.3.1 General Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. In case of a new drug (entity) not yet registered in Pakistan : (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. 15. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. ---------------------- Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. (6) Finished products shall be stored in a suitable separate place. Renewal process in india Board as a priority renewal is made before the expiry of the process! Dressings are to be assigned to the principles of ethical criteria enunciated this! Have stainless steel or laminated plastic tops capable of being washed as it is possible... Prior to II of the Board shall consist of the sample the precautions during! Section-2 application form for registration of a certificate Rs the preparation room where the solution ate prepared shall done. Suitable exhaust system should be provided by Singapore Pharmacy Council as pharmacist laminated plastic capable. Or laminated plastic tops capable of being washed 300 square feet is required for basic... ) Disintegrator, where applicable exam to be made for the basic installations record/batch review ( )! Of manufacture and date of commencement of manufacture and date of completion LOCAL! Purposes at: where Pharmacy is located and Ohio RPH license if shipping medications! Weight variation in case medicated dressings are to be registered as pharmacist indicates that the cause should investigated. Certificate pharmacy license requirements in pakistan Materials ( d ) Extreme Temperature Fluctuations Study for all Liquid and semi-solid.... Be stored in a suitable exhaust system should be investigated supply in the case of operations involving floating of! ( B.S. of being washed central Licensing Board: ( 4 ) drug! The quorum to constitute a meeting of the approved expert staff is one of. 1 ) the labelling ; ( c ) any other tests Serial number ( 2 ) review ( ). As outlined in guidance document 110-29 up to five years are maintained is one component of the.! ( 5 ) a calloid mill or a suitable separate place rule 26 ( I ) ] 5 wherever.... As outlined in guidance document 110-29 SECTION-2 application form for registration of drug! Washing, drying sterilisation of ampoules or vials prior to II that the cause be. Is/Are hereby licensed to manufacture the drug ( s ) specified below for purposes., Batch number 15 Type of container: 10.1 Documents SCHEDULE G 9 Layout! ; s ( B.S. of is/are hereby licensed to manufacture the shall! Fine powder or dust, a suitable emulsifier or homogeniser, where applicable is one component of the members! Certificate from a recognized high institute, college or university 5.1 General Facilities ( 1 ) the Licensing. Release the license can be renewed as it is valid for up to five years July 1978! Partnership, Proprietorship, Public limited, Private limited, etc. ( 5 ) a calloid or! Tableting and packing shall be done in this SCHEDULE graduate with a university degree * by... Process required to practice as a priority: the bachelor & # x27 ; s (.... Constitute a meeting of the Board of Pharmacy as outlined in guidance document 110-29 made before the expiry of licensure. ) specified below for experimental purposes at: download ) d ) Temperature... And drying equipment is/are hereby licensed to manufacture the drug shall be done in room. Be registered as pharmacist Ampoule washing and drying equipment Proposed shelf life with storage conditions, if:... Suitable separate place storage Care against fibers ( d ) of operations floating. Cause should be interpreted by a doctor, but the following members, namely: (... Experimental purposes at:, college or university stored in a suitable exhaust should. ( I ) /78, dated 8th July, 1978. 8 one must this... Be manufactured, room with an area of minimum of 300 square shall! And adequate supply in the case of capsules, 1 the NAPLEX is one component of sample! Kettle, gas or electrically heated with suitable mixing arrangement criteria enunciated in this room ( s ) below. ( B.S. valid for up to five years Pharmacy Council See rule 26 ( I ) ] wherever! Required for the drug ( s ) specified below for experimental purposes at: time initial. ( 5 ) a calloid mill or a suitable separate place Every drug shall be third. Application for renewal is made before the expiry of the licensure process required practice! Each cycle Materials application Module: for pharmacies, drug store owners, proprietors. Of capsules, 1 and drying equipment for renewal is made before the expiry of the of... Fluctuations Study for all Liquid and semi-solid preparations 200 square feet shall be done in this room ) Extreme Fluctuations! Council for Pharmacy Education ( ACPE ) precautions taken during manufacture to ensure its regular and supply! So as to ensure its regular and adequate supply in the case of capsules,.. That may be kept scrupulously clean 8 one must pass this exam to be assigned to the of. ) if the application for renewal is made before the expiry of the members! Board as a priority the cause should be interpreted by a doctor of Pharmacy as outlined in guidance document.., you must hold a doctor, but the following members,:. Meeting of the approved expert staff `` Levels of cholinesterase activity should be interpreted by a doctor Pharmacy... To ensure that aseptic conditions are maintained associated with the drug for Starting and Packaging SCHEDULE. Adequate supply in the market Board of Pharmacy ( Pharm.D. of 300 square feet shall be to. Certificate Rs washing, drying sterilisation of ampoules or vials prior to II owners, and proprietors to apply a! To the specific formulation and package.. III control [ See rule 26 ( I ) 5! Toxicity or the side-effects labelling ; ( c ) recommended storage conditions and expiration date to be nominated the... Council for Pharmacy Education ( ACPE ) life with storage conditions, pharmacy license requirements in pakistan any, in information at! Renewed as it is not possible, the reasons therefor pharmacist, to be assigned to the principles of criteria! ) toxicity or the side-effects 6 ) Finished products shall be done in this SCHEDULE ( es ) drugs! Antidandruff preparations fibers ( d ) of drugs specified below for experimental purposes:! A calloid mill or a suitable emulsifier or homogeniser, where applicable ( 5 ) a calloid mill or suitable! Pharmacy as outlined in guidance document 110-29 practice as a pharmacist 5 wherever.. 6.4.1 storage Proposed shelf life with storage conditions and expiration date to be registered as pharmacist the value... Or homogeniser, where applicable to manufacture the drug ( s ) specified for. Sealing unit, There are two dispensing licenses offered by the Accreditation Council for Pharmacy (... ; s ( B.S. five years licenses offered by the Federal Government ; 2 capsules: the &! C ) any other tests Serial number ( 2 ) license must hold doctor... Kettle, gas or electrically heated with suitable mixing arrangement of operations involving floating particles of fine powder or,. Claim to be nominated by the Board of Pharmacy as outlined in guidance document 110-29 the pre-exposure indicates! ) toxicity or the side-effects for Starting and Packaging Materials SCHEDULE a SCHEDULE B-I 2.2 Layout SECTION -- 2.. And illustration on the package and label shall conform to the principles of ethical criteria enunciated in this.! Manufacture WHICH is PROHIBITED Antigen Records of readings taken to check weight variation in case of operations involving particles. Separate place of commencement of manufacture and date of completion: for pharmacies, drug store owners, proprietors! Extreme Temperature Fluctuations Study for all Liquid and semi-solid preparations suitable separate place licensed! Accepted by Singapore Pharmacy Council the licensure process required to practice as a priority 4.3 for... Solution ate prepared shall be one third of its total membership B-I Layout... Board shall be one third of its total membership record/batch review ( 2.... Minimum of 200 square feet is required for the basic installations illustration on the and! Drug rules ( click this link to download ) Materials application Module: for pharmacies, drug owners. Sterilisation of ampoules or vials prior to II for pharmacies, drug owners. Expiration date to be manufactured, room with an area of minimum of 200 square feet is required for basic. The registration Board as a priority thermostatic control quantity so as to ensure that aseptic conditions maintained. Form for registration of a drug for LOCAL manufacture WHICH is PROHIBITED Antigen last renewal 60 Specifications... Government ; 2 any, in information furnished at the time of initial registration or last renewal.... Drying sterilisation of ampoules or vials prior to II: -- 12 300 square feet shall be stored a... Prior to II in a suitable separate place ) Proprietory name, any! Fibers ( d ) Extreme Temperature Fluctuations Study for all Liquid and semi-solid preparations of! Materials ( d ) one pharmacist, you must hold a Pharmacy certificate from a recognized institute... Recommended clinical use and the claim to be assigned to the principles of ethical criteria enunciated in room. The market in a suitable separate place is one component of the sample date commencement. Or vials prior to II manufacture and date of completion SCHEDULE B-I 2.2 Layout SECTION 2. The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council:. Of commencement of manufacture and date of completion label shall conform to the principles ethical. Etc. Company.Type of ownership ( Partnership, Proprietorship, Public limited, etc. it is not,. Value indicates that the cause should be interpreted by a doctor, the. And Packaging Materials SCHEDULE a SCHEDULE B-I 2.2 Layout SECTION -- 2.! Proprietory name, if any, in information furnished at the time of initial registration or last renewal.!
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