SOLITAIRE PHARMACIA PVT. LTD.

  1. Objective

To define the procedure for entry and exit in Production packing areas

  1. Scope

This SOP is applicable to all personnel while entering and exit in Production packing areasat Solitaire Pharmacia Pvt. Ltd., Baddi.

  1. Responsibility

Executive Q.A

ExecutiveProduction

Executive Engineering

  1. Accountability

Head Q.A

HeadProduction

  1. Procedure
  1. Entry And Exit Procedure For Primary Changeroom

(Operator, Worker)

  1. Entry and Exit in the Production areas is through the respective “PRIMARY CHANGE ROOMS” only.
  2. Enter the respective primary change room, leave the personel belongings in the designated lockers

Note:Remove ear rings, chains, bangles, wrist watches and other ornaments and keep in lockers before entering the Production area.

  1. Wash the hands with water.
  2. Dry the hands under the hand dryer.
  3. Remove the street footware & street clothes, place them in designated place.
  4. Swing over the cross over bench and wear the Plant’s footware.
  5. Cap shall be worn to cover the hair completely.
  6. Wear factory clothes
  7. Sanitize the hand with 70% v/v IPA .
  8. Check for the proper dressing .
  9. Proceed toward the production area.
  10. Personnel leaving the production areas shall enter the primary change room, remove the primary factory uniform and keep it in the locker, then wear street clothes.
  11. Remove the Primary factory footwear & place it in the rack, crossover and wear the street footwear and exit through the primary changeroom.
  12. Entry And Exit Procedure For Secondary Changeroom

(Operator, Worker)

5.2.1. Enter the secondary change room.Remove the Primary factory footwear & keep it in the shoe rack.Swing overcrossover bench, and wear the secondary factory shoes.

5.2.2.Wear the Secondary uniform over the primary factory uniform.

5.2.3.Moisten the hands with disinfectant solution rub the solution on the hands.

5.2.4.Personnel entering the process areas, shall wear, nose-mask and foot cover.

5.2.5.Personnel leaving the Production areas shall enter the secondary change room, remove the secondary uniform and keep it in the designated locker

5.2.6.Remove the secondary shoes & place it in the crossover bench swing over the crossover.

5.2.7.Wear Primary factory footwear and exit through the secondary changeroom.

5.3.Entry And Exit Procedure For Primary Changeroom (Staff)

  1. Enter the respective primary change room, leave the personel belongings in the designated lockers Note:Remove ear rings, chains, bangles, wrist watches and other ornaments and keep in lockers before entering the Production area.
  2. Wash the hands with water.
  3. Dry the hands under the hand dryer.
  4. Remove the street footware place them in designated place.
  5. Swing over the cross over bench and wear the Plant’s footware.
  6. Cap shall be worn to cover the hair completely.
  7. Wear factory clothes
  8. Sanitize the hand with 70% v/v IPA .
  9. Check for the proper dressing .
  10. Proceed toward the production area.
  11. Personnel leaving the production areas shall enter the primary change room, remove the primary factory uniform and keep it in the locker, then wear street clothes.
  12. Remove the Primary factory footwear & place it in the rack, crossover and wear the street footwear and exit through the primary changeroom.
  13. Entry And Exit Procudure For Secondary Changeroom

(Staff)

  1. Enter the secondary change room.
  2. Moisten the hands with disinfectant solution rub the solution on the hands.
  3. Swing overcrossover bench.
  4. Personnel entering the process areas, shall wear, nose-mask and Hand Gloves.
  5. Personnel leaving the Production areas shall enter the secondary change room.
  6. Exit through the secondary changeroom.

5.4.Entry And Exit Procedure For Primary Changeroom (Visitors)

5.4.1.enter into the staff primary change room.

5.4.2.Leave the personal belongings in the designated Lockers.

5.4.3.put the shoe cover over the footwear and cross over thebench.

5.4.4.Wear disposable coat over the street cloth and cap to coverthe head.

5.4.5.Wash the hands with the liquid soap & water.

5.4.6.Dry the hands under the hand dryer.

5.4.7.Proceed toward the production area.

5.4.8.Visitors leaving the production areas shall enter the primarychange room.

5.4.9.Swing over the crossover bench remove the Apron, cap & mask and keep it in the bin labeled as “USED”.

5.4.10.Discard the shoecovers in the bin labled as “USED SHOE COVERS” & exit through primary changeroom.

5.4.Entry And Exit Procedure For Secondary Changeroom Visitors

5.4.1.Enter the secondary change room.

5.4.2.Swing over the crossover bench, and wear the secondaryshoe cover.

5.4.3.Moisten the hands with disinfectant solution rub the solution on the hands.

5.4.4.Visitors who enter the process areas, shall carry hand gloves and nose-mask and wear them before entering the processing areas.

5.4.5.Proceed to the respective Production area

5.4.6.Visitors leaving the Production areas shall enter the secondary change room & exit through secondary changeroom.

  1. Records/Formats

NA

  1. Annexure

Annexure-1 - Instruction forStaff/Operator/Worker/Visitors

  1. Reference

Nil

9. Abbreviations

SPL- Solitaire Pharmacia Pvt. Ltd., Baddi.

PR- Production

SOP - Standard Operating Procedure

Q.A - Quality Assurance

N.A - Not Applicable

  1. Revision History:

Revision No. / Effective Date / Reason for Revision
00 / New Document

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

ANNEXURE NO. I

Entry procedure and gowning instruction for

staff/operator/worker/visitors

1. / Every person entering in the Production area shall wear protective garments as per the procedure of respective area.
2. / Carrying food, drink and smoking materials or personnel medication in the production and storage areas shall be prohibited.
3. / Eatables, Drinks, smoking & tobacco chewing are prohibited inside the production area.
4. / Any unhygienic practice within the Production areas or in any other area where the product might be adversely affected shall be forbidden.
5. / Watches, Finger rings, wristwatches, bangles, flowers and other ornaments are not allowed inside production area.
6. / Hairs are not to be combed inside the production area.
7. / Whistling or singing shall be forbidden in the production areas.
8. / Visitor enters into the processing cubicle (where the products are directly exposed), shall ensure to wear a Cap, mask and hand gloves.
9. / Direct contact shall be avoided between the person's hand and the exposed product as well as with any part of the equipment that comes in contact with the products.

Format No.SPL/QA/001