ENVIRONMENTAL

Medicraft Pharmaceuticals (Pvt) Ltd. Peshawar	Page No.	1 of 4
Job Descriptions	ISO No.	JD/1/024
	Issue	2

Part 1

Designation: Manager Research and Development

Department: Research and Development

Reports to: Production Manager

Part 2

Broad Functions:

1. Responsible for supervising all the activities in his area of responsibilities such as launching of new products according to latest research, improving and economizing the existing formulations.

2. Responsible for supervision and control of staff reporting to him as per company’s policies and procedures maintaining high level of GMP, safety and housekeeping requirements in R&D Section.

Part 3

Principal Responsibilities:

Responsible for supervision and control of work related activities in his area of responsibilities as described below:

1. Supervise the development of formulations for newly discovered drugs in light of modern research.

2. Pinpoint the defect in the existing formulations in consultation with the production manager and supervise the manufacturing of the trial batch.

3. Discuss with production manager suggestion for the economizing of the productivity improvement and improving the quality of the product.

5. Ensure that all the precautions are practiced before starting, during and after the completion of the trial batch, e.g. cleanliness of equipment and area, humidity and temperature control, etc.

6. Ensure proper housekeeping and cleaning as per relevant SOPs.

7. Assign daily jobs to R & D officer.

8. Ensure to fulfill the daily production target in the assigned area.

9. Notify the Production Manager / maintenance department any breakdown of process / service equipment and any subsequent delay in production.

10. Inform, persuade and convince staff reporting to him of the benefits of GMP, Safety, Quality and ensure that our products maintain best quality.

11. Ensure that the manufacturing sections are complying with the standard procedures related to GMP / SH&E set by the company.

12. Carry out audit of manufacturing and pinpoint violation GMP/SH&E standards to the person responsible for it and arrange for its rectification on priority basis.

13. Responsible for proper outfit, cleanliness and hygiene of the staff reporting to him.

14. Ensure the security and safety of equipment/ products and personnel in the section.

15. Pinpoint any safety hazard/unsafe practices and take an appropriate action for its rectification.

16. Check late comings, and act of indiscipline of the staff reporting to him by taking immediate action.

17. Training / development of the new colleagues including management and non–management staff.

18. Recommend increment of the staff reporting to him.

19. Follow and implement all the policies and procedure of the company as communicated from time to time in his section, permanently or temporarily.

20. Attend courses / meeting as and when required.

21. Bring about improvement in the working of the section through creative and innovative ideas.

22. He is authorized to recommend leave of his subordinate.

23. He will perform any other work assigned by production manager / factory manager / director(s) from time to time as per business requirement.

24. He is responsible to supervise and manage the work of his sub – ordinates and authorize to:

    1. Recommend overtime, leave etc.

    2. Transfer, promotion, demotion etc.

25. Staff reporting to him:

    1. Section Incharge.

    2. Supervisors.

    3. Workers.

26. Area of responsibilty:

    1. Production Deptt.

Part 4

Principal Relation:

1. Contacts Inside the company:

   1. Frequently remains in contact with Production Manager, Incharge RMS/PMS, Supervisor Printing Section, Supervisor Finished Goods Store, Tablet Section Incharge, Supervisors and workers in his section.

2. Outside the company:

   1. Nil

Part 5

Supplementary Information:

Education: B. Pharmacy / Equivalent Degree.

Experience: Minimum 2 to 3 year but not necessary.

Skills: Computer literate but not necessary.

a system and instructions and to assign responsibilities

3Medicraft Pharmaceuticals (Pvt) Ltd. Peshawar	Page No.	1 of 1
Title: Procedure for Training and Skill Development.	ISO No.	HRD/2/001
	Issue	1
	Supercedes	Issue 2 of HRD/2/001
	Effective Date	October, 2005
	Revision Date	October, 2006

1. Purpose :

• To ensure that all employees receive adequate training in approved procedures, manufacturing skills, and safety to meet or exceed customer expectations.

• To provide for a system and instructions and to assign responsibilities for determining training needs, providing the training, and keeping training records.

2. Scope :

• This procedure applies to all training activities at Medicraft Pharmaceuticals.

3. Responsibilities

• Human Resource Department is responsible for all new or transferred employees to meet the minimum requirements for the position being filled, by initiating and ensuring all the necessary trainings on time, with the coordination of MR.

• Human Resource Manager identifies with the coordination of MR ensures that all necessary training is received by the staff.

• HRM with the coordination of MR is responsible for making the necessary arrangement regarding the training session, such as arranging a training instructor, etc.

4. procedure

   1. orientation to new employees AND OTHER TRAININGS TO ALL THE CONCERNED EMPLOYEES.

1. Orientation to new employees includes orientation on administration policies (e.g., working hours, leaves, medical, disciplinary policies etc.), understanding of Quality Policy, Job description, and on – job training.

2. HR Manager initiates the planning of the training by maintaining the format of Training Plan for the Year 200X.(HRD/4/004) and coordinate with MR in case if any alteration is required to be made in the planning,

3. The training plan is made for a particular time period, tentatively for 3 months.

4. All the section/ department heads also plan and maintain the format of Training Plan for the Year 200A(HRD/4/004) and send them with MR in case if alteration is required to be done.

5. MR after analyzing the Training Plans duly adjusted for the dates and times, sends copies of all to HRM and concerned copies to each section with one copy of HRD Training Plan.

6. Training Request Form (HRD/4/001) is used if an external training is required.

7. Training Form (HRD/4/002) is maintained during training by the trainer. The Training Form (HRD/4/002) is then sent to HRD to update the Individual Employees Training Record(HRD/4/003). During the training session, performance of each trainee is evaluated.

8. In case of departmental / sectional training the Training Form (HRD/4/002) is maintained, the data from which is transferred to Individual Employee Training Record (HRD/4/003) within the section, and the Training Form is sent to HRD for updating of Central folder for Individual Employee Training Record (HRD/4/003).

9. All the departments updates the Individual Employees Training Record(HRD/4/003) from time to time by keeping liaison with Central Folder for Individual Employee Training Record (HRD/4/003)

10. Unplanned training if required to be done, then MR and HRD is communicated via Internal Memo (MR/4/006).

11. Individual Training Record Forms are maintained at the relevant department/sections.

2. EVALUATION OF EMPLOYEES.

Employees are evaluated by the head / Incharge of each section / department by maintaining the Form Employees Performance Evaluation form (HRD/4/005) and is communicated to HRD.

5. related documents

Nil

5. related records

1. Training Request Form, HRD/4/001

2. Training Form, HRD/4/002.

3. Individual employee training record HRD/4/003.

4. Training Plan for the year 200A HRD/4/004.

5. Employees performance evaluation form HRD/4/005

7. ANNEXURE

Nil.

7. CHANGE CONTROL HISTORY

Procedure for Training and Skill Development was revised in the month of November 2005 and it has replaced issue 2 of the document HR/2/01 with issue 1 of HRD/2/001

Written By	Reviewed By	Authorized by:
Aman Shah	Farooq Khan	Ashfaq Ahmad
HRM	MR	Director Admin./ Acct.
Date:	Date:	Date:

EXPORT OF MEDICINE TO OTHER COUNTRY

CERTIFICATE OF PHARMACEUTICAL PRODUCT 1
(This Certificate conforms to the format recommended by the World Health Organization)
Certificate No: _
Issued Date: Exporting Country: Pakistan
Importing Country: Vietnam
Proprietary name (if applicable) and dosage form:
Active Ingredient (s) and amount (s) per unit dose3: (Complete qualitative composition including excipient): See 1. Is this product licensed to be placed on the market for use in the exporting country?4 Yes / No (If Yes, complete Box A, if No Complete Box B)

A) Product License holder:
Medicraft Pharmaceuticals (PVT) LTD.
126-B Industrial Estate Hayatabad Peshawar, Pakistan.
Mfg. License No: 000390 Date: 26.06.2004

b) Status of the license holder5


c) Number of product license6 and date of issue: 000650EX Dated-13.03.2007

d) Is an approved technical summary appended?7 Yes / No
e) Is the attached product information complete and consonant with the license?

Yes No Not Provided

Application for certificate if different form the license holder. NA


B) Application for certificate: Not applicable

b) Status of the license holder5




2. a) Does the certifying authority arrange for periodic inspection of manufacturing plant in which the dosage form is produced?
Yes No (If no proceed to Question 3)
b) Periodicity of routine inspections (Years): 2 Times per Year. Yes No
c) Has the manufacturer of this type of dosage form been inspected. Yes No
d) Do the facilities and operations conform to GMP as recommended by the World Health Origanization?10 Yes No
3. Do the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacturing of the products undertaken by another party?11

Yes No (If no, Explain)

Address of certifying authority: Name of authorized PersonDesignation:
Signature, Date & Stamp:

GENERAL INSTRUCTIONS

PLEASE REFER TO THE GUIDELINES FOR FURTHER INFORMATION ON HOW TO COMPLETE THIS FORM AND ON THE IMPLEMENTATION OF THE SCHEME.
Forms should be completed using a type writer to ensure legibility.
Across should be in squares as appropriate to indicate which option apply.
Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

EXPLANATORY NOTES

1. This certificate, which is in format recommended by the WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country, it is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.
2. Use, whenever possible, international nonproprietary names (INN) OR National proprietary names.
3. A qualitative listing of other ingredients contained in dosage form should be appended.
4. When applicable append details, if any restriction applied to sale, distribution or administration of the product that is entered on the product license.
5. Specify whether the person responsible for placing the product on the market:
a) Manufacture the active ingredients and the finished dosage form,
b) Manufacture the finished dosage form,
c) Package and / or labels, a finished dosage form manufactured by an independent company, or
d) Is involved in none of the above:
6. Indicative, when applicable, if the license is provisional, pending technical review.
7. This refers to the documents, prepared by certain national regulatory authorities, the summaries the technical basis on which the product has been licensed.
8. In the circumstance, permission for issuance of the certificate is required from the product license holder.
9. Please indicate the reasons the application has provided for non requesting registration.
a) The product has been developed exclusively for the treatment of condition-particularly topical disease-non endemic in the country of export.
b) The product has been reformulated with a view to importing its stability under topical conditions.
c) The product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the country of import.
d) The product has been reformulated to need a different maximum dosage limit for an active ingredient.
e) Any other reasons please specify.
10. The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate are those adopted by the Twenty Eight World Health Assembly in its resolution WHA 27–65.
(See WHO Official Records No 226.1975, Part–1 Annexure 12). Proposal for the amendment of these requirements and included in the thirty second report of the WHO expert committee on specifications for pharmaceutical preparations. Recommendations specifically applicable to biological products have been formulated by the WHO expert committee on biological standardization (WHO Technical report series No. 822.1992, Annexure 1).
11. This section is to be completed when the product license holder or applicant conforms to status (c) or (d) as described in note 5 above. It is of particular importance when foreign contractors are involved in the manufacture of the product.
In these circumstance, the applicant should supply the certifying authority with information to identify the contracting parties responsible for each stage of manufacture of the finished dosage form and to indicate the extent and nature of any control exercised over each of these parties.