SOP for Prevention of Product Mix-ups and Cross-Contamination

PURPOSE

To lay down the procedure for preventing product mix-ups and cross-contamination.

SCOPE

This procedure is applicable to all activities in the Equipment/Machine, area, Materials in stores, QC, and production department at PharmaInfo Ltd.

RESPONSIBILITY

• User Department Person: To follow the system necessary to prevent contamination and cross-contamination.
• Concerned Department Head: To ensure SOP implemented in the manufacturing facility
• Quality Assurance Head: To ensure implementation of the defined system.
• Quality Head: To ensure & arrange external training.
• Plant Head: To ensure & arrange external training.

DEFINITION

Contamination: 

• The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.

Cross-Contamination:

• Contamination of a starting material, intermediate product, or finished product with another starting material or product during production.

PROCEDURE

Pharmaceuticals cross-contamination refers

• Cross-contamination of products may be harmful & life-threatening to the patient.
• Most significant cross-contamination such as steroids, penicillin, Cytotoxic, Hormones, pathogens, etc are hazardous & be prevented through facility & control defined in GMP.
• The main source of cross contaminations in drug manufacturing and other activities are Human beings, air, Equipment/Machine, Water, and Raw materials for consideration should be taken of these factors

Facility Design

• Health & Hygiene
• Sanitization practices
• Unwanted movements
• Cleaning and disinfection (Drain/Facility)
• Environment monitoring
• Environment criteria

ALSO READ: SOP for Quality Risk Assessment and Quality Risk Management (QRM)

Material Management

• All raw materials, both actives and excipients shall be procured only from approved suppliers.
• Store personnel receiving the material shall follow all steps with respect to handling and storage of raw materials and packing materials as per respective SOP.
• Special attention shall be provided to verify and tally the labels of containers and indented items on receipt. On in-process material should specify the process stage.
• While storing the material, care shall be taken to ensure segregation of different stages like under test, approved, and rejected materials
• Any rejected or obsolete materials shall be suitably disposed of within the shortest possible time and records shall be maintained accordingly.

• Dispensing of the materials shall be done only after obtaining line clearance and dedicated cleaned scoops shall be used for dispensing.
• All the materials in the warehouse shall be stored over the Racks (preferably powder-coated).

Quality Control of Incoming Materials

• QC shall follow the various steps detailed under specific sampling procedures.
• Special precautions shall be taken by QC to ensure that no cross-contaminations occur while sampling.
• Dedicated or appropriately cleaned sampling equipment shall only be used for sampling.
• During sampling, QC personnel shall critically verify the labels on the containers.
• QA Manager shall periodically carry out the review of the laboratory activities and ensure that the laboratory systems and procedures are sufficient to detect any mix-ups or cross-contamination.

Manufacturing & Packing

• The production person receiving the materials issued by stores shall carefully verify the labels on the containers and tally them with the indent.
• QA person shall crosscheck any weights and addition of materials in manufacturing
• Line clearance procedures shall be strictly followed and documented by production & QA.
• The effectiveness of cleaning shall be validated and records shall be maintained.
• Adequate in-process checks shall be in place at appropriate stages to ensure that the manufacturing proceeds as per the plan.
• QA shall carry out periodic reviews of all manufacturing activities to ensure that there is no potential for mix-ups or cross-contamination.
• Care and precaution during product manufacturing, handling of finished products, in-process manufacturing controls, labeling controls, validated cleaning procedures, and quality control procedures in addition to general GMP compliance shall be given top priority.
• All the materials inside the production facility shall be stored in sealed polythene bags, in closed drums with proper identification status. For example, in-process materials and finished drug products shall be stored, with a clear identification status label.
• All the materials in the production shall be stored over the pallets (preferably of stainless steel). Packing lines shall be independent and adequately segregated. All the remains of previously packed materials (such as labels, left-over, cartons, caps, etc) shall be removed before the start of the next operation.
• All printing and overprinting shall be authorized in writing by production and quality assurance.

• Providing appropriate airlocks, pressure differentials, and air extraction.
• Manufacturing environment conditions shall be maintained at the required level of temperature and humidity.
• The proper gowning procedure shall be followed to prevent personnel contamination. Access of unauthorized persons, to control areas such as Production, and Warehouses be restricted.
• Any OOS or typical results obtained by QC during the analysis of raw materials, intermediates, and finished products shall be investigated in detail before the batch is accepted or released.
• QA Head or his personnel shall conduct training programs from time to time regarding mix-ups and cross-contamination and the impact of the same on the product quality. If possible, live examples shall be given to highlight such situations.

Prevention and handling of contamination with metal objects

• Restrict the use of metal-like objects to the minimum.
• Wherever it is unavoidable, use metal objects with strict control. Items like knives, scissors, pins, nuts, bolts, sieves, and sampling equipment should be used with care and caution.
• Before the start of the operation and after completion of the operation, check the nuts and bolts, which are used for the equipment for its absence and/or loosening. Wherever nuts and bolts are loosened, the same should be tightened. In case any nuts and bolts are missing, the same should be investigated.
• During regular preventive maintenance or breakdown maintenance, special attention should be given to nuts and bolts so as to prevent contamination with the same. After preventive maintenance or breakdown maintenance, QA should give line clearance to ensure that the area/equipment is free from grease, nuts, bolts, and any other maintenance tools.
• Man and material movement strictly followed.
• Differential pressure is maintained at different frequencies.
• Minimum personnel should be present in the area when handling/Processing of material takes place.
• Unnecessary movement should be avoided.
• Activities shall be followed as per defined procedures.

ATTACHMENT

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ABBREVIATION

QA: Quality Assurance

QC: Quality Control

SOP: Standard Operating Procedure

cGMP: Current Good Manufacturing Practices.

GDP: Good Documentation Practices

REVISION HISTORY

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