GMP SOP Form-160 2017-2025 free printable template

Form-160 Issue date Line Clearance Opening and Cleaning for Tablet Packing line Ref. SOP MAN-055 MAN-075 Line Opening Product Date Line Cleaning Relevant process SOP SOP MAN-075 BPN Code No. Pack Size Type of Change Change of Product Packing Line Change of BPN. Change of Code. Tick operations which are ACCEPTABLE Put a N/A against any operations NOT APPLICABLE N/A If unacceptable standard is found have it corrected BEFORE proceeding and note details of any NonCompliance into TABLE B of this...

How to fill out gmp sop template form

How to fill out GMP SOP Form-160

1. Start by downloading the GMP SOP Form-160 from the official website.
2. Read the instructions provided at the beginning of the form to understand the requirements.
3. Fill in the date at the top of the form.
4. Enter the name of the organization or individual submitting the form in the designated field.
5. Provide the address, including city, state, and zip code, in the corresponding sections.
6. Identify the specific Standard Operating Procedure (SOP) number related to this form.
7. Outline the purpose of the SOP in a clear and concise manner.
8. Specify the effective date for the SOP.
9. Include the names and signatures of the individuals responsible for preparing and approving the SOP.
10. Review the completed form for accuracy and completeness before submission.

Who needs GMP SOP Form-160?

1. Manufacturers and suppliers of pharmaceutical products who are required to document their standard operating procedures.
2. Quality control personnel who need to ensure compliance with regulatory standards.
3. Auditors and inspectors who evaluate the adherence to GMP guidelines.
4. Training staff who need to document their SOPs for standardization and training purposes.

People Also Ask about gmp checklist template

What is line clearance in API?

Line clearance is a process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing's before proceeding for next process.

What is the guideline before line clearance?

Line Clearance Checklist for Compression: Waste Bin is cleaned. All the equipment inside the room including SS table utensils and scoops are cleaned. All materials/ equipments are labeled properly. All protective clothing of processing personnel i.e. dress, shoes, caps, masks, hand gloves are properly cleaned.

What is SOP for area line clearance?

SOP For Line Clearance Sr.No.Check List1.Check and ensure that the area/equipment are visually clean & “CLEANED” label attached to the equipment.2.Ensure the area is free from previous product and unwanted materials.3.Ensure the temperature and relative humidity are within the specified limit8 more rows • Dec 25, 2020

What is the checklist for line clearance?

Line Clearance Checklist for Coating Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR. Check the differential pressure of the area is –ve with respect to the adjacent corridor. Check the proper gowning of personnel. Check the present status label which shows the detail.

What is the procedure of line clearance?

Line clearance is a standardized procedure in manufacturing for ensuring equipment and work areas are free of products, documents, and materials from a previous process. Line clearance procedures help operators prepare for the next scheduled process and avoid mislabeling or cross-contamination of finished products.

When should line clearance be done?

A Line Clearance, Line Opening and Line Cleaning is required with a change of batch production. 1.2. A Line Clearance is done BEFORE a batch starts.

Who is responsible for line clearance?

2 Production officer is responsible for carrying out the line clearance.

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What is GMP SOP Form-160?

GMP SOP Form-160 is a standardized document used within the guidelines of Good Manufacturing Practices (GMP) to ensure compliance with industry regulations and facilitate the documentation of standard operating procedures.

Who is required to file GMP SOP Form-160?

Any manufacturing facility or organization that is involved in the production, packaging, or holding of pharmaceutical products and is subject to GMP regulations is required to file GMP SOP Form-160.

How to fill out GMP SOP Form-160?

To fill out GMP SOP Form-160, one must follow the provided instructions carefully, entering relevant details about the standard operating procedures being documented, including title, version, date, and responsible personnel.

What is the purpose of GMP SOP Form-160?

The purpose of GMP SOP Form-160 is to standardize the format for documenting operating procedures that ensure products are consistently produced and controlled according to quality standards.

What information must be reported on GMP SOP Form-160?

The information that must be reported on GMP SOP Form-160 includes the title of the SOP, revision number, effective date, procedure details, personnel responsibilities, and any applicable references or attachments.