| Title: Sampling of Production Materials and Finished Goods | |||||
| Guidance Number: 077 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Sampling of Production Materials and Finished Goods
Introduction
This document provides guidance for a sampling program for:
- Raw Materials (RM),
- Starting Materials,
- Packaging Materials,
- Labeling,
- In-Process Materials,
- Intermediates,
- Active Pharmaceutical Ingredients (API),
- Drug Products,
- Biologics,
- Medical Devices,
- Medical Device Components, and
- Materials with Direct or Potential Product Contact.
1. Sampling SOPs should include, and are not limited to, the following information:
- Sampling method;
- Sampler apparel;
- Sampling tools, utensils, and equipment to be used;
- Amount of the sample to be taken;
- Instructions for any required sub-division or compositing of the sample;
- Type and condition (e.g., sterile or endotoxin-free) of the sample container to be used;
- Identification of containers sampled;
- Sample identification;
- Any special precautions to be observed, especially with regard to the sampling of sterile or noxious materials;
- Special storage conditions; and
- Instructions for the cleaning and storage of sampling equipment, if disposable sampling equipment is not used.
2. Utensils and Tools used for sampling should be cleaned prior to use, except when approved pre-packaged items, such as sterile disposables, are used.
3. Sampling Area Environmental Conditions should be equivalent to those required for the use of the material in manufacturing.
4. Sterile Materials should be sampled in areas with an air classification of Grade A.
5. Sampling Activities that Occur Outdoors (e.g., tanker trucks, rail cars, and solvent drums) should be performed in a manner to prevent contamination from foreign matter.
6. Sampled Containers should each be labeled to indicate the date on which they were sampled and the name of the sampler. This label should remain in place on the container during all subsequent production use.
7. Apparel for Sampling Personnel, except when sampling non-product-contact materials (e.g., cartons), should include clean clothing and protective attire, such as: head, face, hand, or arm coverings, shoe covers, respirators, or masks, as necessary to protect personnel and the integrity of both the sample and the material being sampled.
8. Sample Names should be the name of the material used in the approved specification for the material. The grade of material should be specified in the name, where applicable.