1. Introduction – Batch Packing Record – Paracetamol Combination Tablets:
This Batch Packing Record (BPR) has been prepared by the QA Department of Pharma Devils for the product: Paracetamol, Bromhexine, Chlorpheniramine Maleate, Phenylephrine Hydrochloride & Guaiphenesin Tablets. The purpose of this document is to provide a comprehensive record of the packing operations carried out for this multi-ingredient formulation, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards.The BPR serves as a vital quality assurance tool, documenting each stage of the packing process in detail. It covers the dispensing of packaging materials, line clearance procedures, overprinting details, in-process checks, reconciliation of materials, and rejection analysis. These records ensure that the product is packed in a controlled environment, free from contamination, mix-ups, or errors, thereby safeguarding patient safety and product integrity. Each tablet in this formulation contains Paracetamol (325 mg), Bromhexine (8 mg), Chlorpheniramine Maleate (2 mg), Phenylephrine Hydrochloride (10 mg), and Guaiphenesin (100 mg), with Tartrazine Lake as the coloring agent. The document emphasizes the importance of protecting the tablets from heat and light, maintaining their stability throughout the shelf life.By maintaining strict documentation of packing operations, the BPR ensures traceability, accountability, and compliance with industry standards. It also provides a framework for identifying and analyzing rejections, thereby supporting continuous improvement in pharmaceutical manufacturing. This introduction sets the foundation for the detailed operational records that follow, highlighting the commitment to quality, safety, and regulatory adherence.
Skip to PDF contentThe flow diagram illustrates the Pharma Packing Process for Paracetamol combination tablets in a clear, sequential manner. It begins with Material Dispensing, where packaging materials are issued and verified. Next is Line Clearance, ensuring the area and equipment are clean and ready for use.
The process moves to Blister Packing, where tablets are sealed in protective strips. In-Process Control follows, involving continuous quality checks and inspection to maintain standards. Finally, Reconciliation and Rejection ensures accurate material accounting and identifies any defects. This structured workflow guarantees product integrity, regulatory compliance, and consistent quality throughout the packing operation.
The flow diagram represents the Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) involved in the Pharma Packing Process for Paracetamol combination tablets. CPPs include sealing roller temperature (160–180°C), machine speed, humidity control, and line clearance verification—each directly influencing packaging integrity. CQAs focus on blister seal quality, overprinting accuracy,
carton and shipper fill quantity, and rejection rate analysis. The process begins with Material Dispensing, followed by Line Clearance, Blister Packing, In-Process Control, and Reconciliation. Maintaining CPPs ensures consistent performance, while monitoring CQAs guarantees product quality, uniformity, and compliance with GMP standards throughout the packing operation.