OBJECTIVE:
To lay down the procedure for safe practices in production.
SCOPE:
This SOP is applicable to the procedure for safe practices in production.
RESPONSIBILITY:
Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
About safe practice:
Safe practices are essential in pharmaceutical production areas to ensure the quality and safety of products, as well as the well-being of workers. These practices include:
Emergency preparedness: Facilities must have emergency plans in place to deal with accidents, spills, and other unforeseen events.
Strict adherence to Good Manufacturing Practices (GMP): This includes maintaining cleanliness and hygiene, following standard operating procedures, and documenting all processes meticulously.
Use of Personal Protective Equipment (PPE): Workers must wear appropriate PPE, such as gloves, masks, and gowns, to protect themselves from hazardous materials and prevent contamination.
Proper handling and storage of materials: Raw materials, intermediates, and finished products must be stored and handled according to established guidelines to prevent degradation and contamination.
Waste management: Hazardous and non-hazardous waste must be segregated, stored, and disposed of properly to prevent environmental contamination.
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PROCEDURE:
Follow the safety instructions during regular production and cleaning.
Wear the primary and secondary dress in the respective change rooms before entering the Production Areas, as per the approved procedures.
Wear the secondary shoes before entering the secondary production areas.
Walk slowly in the washing areas.
Remove any water / powder spillage on the floor immediately by following the approved procedures.
Do not touch the walls, floor with gloved hands.
Do not touch any moving parts. Do not bypass any safety controls.
At the end of the day / shift, ensure that all mains are switched off.
Production Executive has to ensure that the operating personnel are using the respiratory protectors during handling the production of potent drugs.
Use a safety goggles while preparation of coating solution.
Elbow length gloves to be used above the secondary dress in secondary areas.
Inform your superiors immediately if you observed any abnormal things on shopfloor regarding product, machinery and safe practices.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch manufacturing record |
| HDPE | : | High density polyethylene |
| IPQA | : | In process Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/safe-practices-during-production/
