Pharmaceutical Plant Equipment’s Requirement as Per GMP

GMP

Below given details are the Good Manufacturing Practices requirements for the Pharmaceutical Plant Equipment’s

Equipment’s must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and any adverse effect on the quality of products.

Equipment should be installed in such a way as to minimize any risk of error or of contamination.

Equipment should be Qualified before use i.e. Design, Installation, operational and Performance Qualification of the equipment’s shall be completed before use.

Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow i.e. purified water, Potable water and Compressed Air etc.

All service pipework and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases and liquids.

Balances and other measuring equipment of an appropriate range and precision should be available for production and control operations and should be calibrated according to a fixed schedule i.e. Calibration and daily Verification of weighing balances, Calibration of In process checks instruments like Disintegration tester, Friability, LOD apparatus, Vernier  caliper, Hardness and Thickness Tester, leak test apparatus .

Production equipment should be thoroughly cleaned according to a fixed schedule or after product to product change over or batch to batch change over or based upon validity of Cleaned equipment or Dirty equipment’s.

The cleaning, usage and preventive maintenance details shall be mentioned in the respective equipment logbooks separately which shall content Date, Product name, Batch number, cleaning or usage activity start time, End time, activity done by, checked by and type of cleaning or preventive maintenance etc.

Production equipment should not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive, or absorptive to an extent that would affect the quality of the product.

Material of construction of the equipment’s contact part should be Stainless Steel 302, 304, 304L, 316, 316L and Teflon etc.

Defective equipment should be removed from production and QC areas. If this is not possible, it should be clearly labelled as defective to prevent use.

A periodic preventive maintenance schedule shall be prepared for each equipment’s and after each  preventive maintenance equipment’s shall be cleaned.

Closed equipment should be used whenever appropriate. Where open equipment is used or equipment is opened, precautions should be taken to minimize contamination.

Non-dedicated equipment should be cleaned according to validated cleaning procedures between being used for production of different pharmaceutical products to prevent cross-contamination.

Current drawings of critical equipment and support systems should be maintained.

Reference WHO Technical Report Series : TRS986annex2

https://pharmaceuticalupdates.com/2020/04/03/good-manufacturing-practices-for-pharmaceutical-products-plant-premises-requirements/

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s